Approved Drug Product List - Orange Book
Page 1 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
This list refers to drug products approved under an Abbreviated New Drug Application (ANDA) that
FDA has selected as reference standards and the associated reference listed drugs (RLDs). The
purpose of this list is to assist applicants submitting an ANDA to seek approval of a generic drug
in identifying an RLD when an ANDA RS has been selected. If the applicant has a question about
which listed drug it should refer to as the RLD, the applicant may consult with FDA (refer to
section 1.4 Reference Listed Drug and Reference Standard of the Orange Book Preface for more
information).
This list is updated monthly. Information in this list is sorted by Active Ingredient(s), Dosage
Form, Route, Trade Name, Applicant Name and Strength. Additional information included are
marketing status (RX, OTC, DISCN), Application Number, Product Number, and approval date of the
Reference Standard.
DESCRIPTION
Approved Drug Product List - Orange Book
Page 2 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
ABACAVIR SULFATE
TABLET;ORAL
ABACAVIR SULFATE
HETERO LABS LTD
III
EQ 300MG BASE A091560 001 Sep 13, 2013RX RLD: N020977
ABACAVIR SULFATE; LAMIVUDINE
TABLET;ORAL
ABACAVIR SULFATE AND LAMIVUDINE
CIPLA EQ 600MG BASE;300MG A091144 001 Mar 28, 2017RX RLD: N021652
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
LUPIN LTD EQ 300MG BASE;150MG;300MG A202912 001 Dec 05, 2013RX RLD: N021205
ACETAMINOPHEN
SOLUTION;INTRAVENOUS
ACETAMINOPHEN
SANDOZ 1GM/100ML (10MG/ML) A204052 001 Mar 22, 2016RX RLD: N022450
ACETAMINOPHEN; BUTALBITAL
TABLET;ORAL
BUTAPAP
MIKART 325MG;50MG A089987 001 Oct 26, 1992RX RLD: A087550
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
DR REDDYS LABS SA 325MG;50MG;40MG A089007 001 Mar 17, 1986RX RLD: A088825
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
STRIDES PHARMA 325MG;50MG;40MG A040511 001 Aug 27, 2003RX RLD: A088616
ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
SPECGX LLC 300MG;15MG A040419 001 May 31, 2001RX RLD: A085055
300MG;30MG A040419 002 May 31, 2001RX RLD: A085055
300MG;60MG A040419 003 May 31, 2001RX RLD: A085055
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
PERCOCET
ENDO OPERATIONS 325MG;5MG A040330 002 Jun 25, 1999RX RLD: A085106
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL
ACETAZOLAMIDE
CADILA 500MG A205301 001 Jan 16, 2019RX RLD: N012945
ACETIC ACID, GLACIAL
SOLUTION/DROPS;OTIC
ACETIC ACID
SAPTALIS PHARMS 2% A040607 001 Feb 24, 2005RX RLD: N012179
ACYCLOVIR
CREAM;TOPICAL
ACYCLOVIR
PADAGIS ISRAEL 5% A208702 001 Feb 04, 2019RX RLD: N021478
SUSPENSION;ORAL
ACYCLOVIR
NOVITIUM PHARMA 200MG/5ML A212252 001 Jul 10, 2020RX RLD: N019909
Approved Drug Product List - Orange Book
Page 3 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
ALBENDAZOLE
TABLET;ORAL
ALBENDAZOLE
DR REDDYS 200MG A211034 001 Jan 26, 2021RX RLD: N020666
ALBUTEROL SULFATE
SOLUTION;INHALATION
ALBUTEROL SULFATE
RITEDOSE CORP EQ 0.021% BASE A214531 001 Dec 28, 2021RX RLD: N020949
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
SOLUTION;INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
NEPHRON EQ 0.083% BASE;0.017% A076749 001 Dec 31, 2007RX RLD: N020950
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
UNICHEM 300MG A211820 002 Mar 12, 2019RX RLD: N016084
ALMOTRIPTAN MALATE
TABLET;ORAL
ALMOTRIPTAN MALATE
AJANTA PHARMA LTD EQ 12.5MG BASE A205523 002 Mar 03, 2016RX RLD: N021001
ALVIMOPAN
CAPSULE;ORAL
ALVIMOPAN
WATSON LABS TEVA 12MG A208295 001 Dec 19, 2019RX RLD: N021775
AMINOCAPROIC ACID
SOLUTION;ORAL
AMINOCAPROIC ACID
TULEX PHARMS INC 0.25GM/ML A212494 001 Aug 11, 2020RX RLD: N015230
TABLET;ORAL
AMINOCAPROIC ACID
SUNNY 1GM A209060 002 Nov 27, 2018RX RLD: N015197
AMLODIPINE BESYLATE; TELMISARTAN
TABLET;ORAL
TELMISARTAN AND AMLODIPINE
MYLAN EQ 10MG BASE;80MG A202516 004 Aug 26, 2014RX RLD: N022401
AMMONIUM LACTATE
CREAM;TOPICAL
AMMONIUM LACTATE
PADAGIS ISRAEL EQ 12% BASE A075774 001 May 01, 2002RX RLD: N020508
AMOXICILLIN
TABLET, CHEWABLE;ORAL
AMOXICILLIN
TEVA 250MG A064013 001 Dec 22, 1992RX RLD: N050542
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
RISING 500MG;500MG;30MG A206006 001 Oct 07, 2016RX RLD: N050757
AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
SANDOZ 250MG;EQ 125MG BASE A065189 001 Aug 23, 2005RX RLD: N050564
SANDOZ INC 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002RX RLD: N050564
Approved Drug Product List - Orange Book
Page 4 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
AMPHETAMINE SULFATE
TABLET;ORAL
EVEKEO
AZURITY 10MG A200166 002 Aug 09, 2012RX RLD: A083901
AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE;ORAL
AMPICILLIN TRIHYDRATE
SANDOZ EQ 500MG BASE A064082 002 Aug 29, 1995RX RLD: N050056
ARGATROBAN
INJECTABLE;INJECTION
ARGATROBAN
HOSPIRA 250MG/2.5ML (100MG/ML) A204120 001 Sep 21, 2016RX RLD: N020833
ARIPIPRAZOLE
SOLUTION;ORAL
ARIPIPRAZOLE
AMNEAL PHARMS 1MG/ML A203906 001 Aug 14, 2015RX RLD: N021713
ARSENIC TRIOXIDE
INJECTABLE;INJECTION
ARSENIC TRIOXIDE
FRESENIUS KABI USA 1MG/ML A208231 001 Aug 31, 2018RX RLD: N021248
ASPIRIN; BUTALBITAL; CAFFEINE
TABLET;ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
STRIDES PHARMA 325MG;50MG;40MG A204195 001 Sep 22, 2016RX RLD: A086162
ASPIRIN; DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE;ORAL
ASPIRIN AND DIPYRIDAMOLE
GLENMARK SPECLT 25MG;200MG A210318 001 May 24, 2019RX RLD: N020884
ATORVASTATIN CALCIUM; EZETIMIBE
TABLET;ORAL
LYPQOZET
ALTHERA PHARMS EQ 80MG BASE;10MG A206084 004 Apr 26, 2017RX RLD: N200153
ATROPINE SULFATE
SOLUTION/DROPS;OPHTHALMIC
ATROPINE SULFATE
AMNEAL 1% A214752 001 Jul 14, 2022RX RLD: N206289
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
SPRAY, METERED;NASAL
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
APOTEX 0.137MG/SPRAY;0.05MG/SPRAY A207712 001 Apr 28, 2017RX RLD: N202236
BACLOFEN
TABLET;ORAL
BACLOFEN
RUBICON 5MG A209102 001 Nov 28, 2017RX RLD: N017851
BENZONATATE
CAPSULE;ORAL
BENZONATATE
PURACAP PHARM LLC 100MG A206948 001 Dec 19, 2018RX RLD: N011210
200MG A206948 002 Dec 19, 2018RX RLD: N011210
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
GEL;TOPICAL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
GLENMARK SPECLT 5%;EQ 1% BASE A209252 001 Mar 14, 2019RX RLD: N050756
Approved Drug Product List - Orange Book
Page 5 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
BETAMETHASONE VALERATE
AEROSOL, FOAM;TOPICAL
BETAMETHASONE VALERATE
TARO 0.12% A208204 001 May 24, 2017RX RLD: N020934
BETHANECHOL CHLORIDE
TABLET;ORAL
BETHANECHOL CHLORIDE
AMNEAL PHARM 10MG A040855 002 Nov 21, 2007RX RLD: A088440
25MG A040855 003 Nov 21, 2007RX RLD: A088441
BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
BIMATOPROST
ALEMBIC 0.03% A210263 001 Apr 12, 2019RX RLD: N021275
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
TABLET, CHEWABLE, TABLET, CAPSULE;ORAL
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
NOSTRUM LABS INC 262.4MG, N/A, N/A;N/A, 250MG,
N/A;N/A, N/A, 500MG
A202584 001 Nov 30, 2018RX RLD: N050719
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMFENAC SODIUM
ALEMBIC EQ 0.09% ACID A210560 001 Jun 21, 2019RX RLD: N021664
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
MYLAN EQ 5MG BASE A077226 001 Apr 04, 2005RX RLD: N017962
TABLET;ORAL
BROMOCRIPTINE MESYLATE
PADAGIS US EQ 2.5MG BASE A077646 001 Oct 01, 2008RX RLD: N017962
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SYRUP;ORAL
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
PADAGIS US 2MG/5ML;10MG/5ML;30MG/5ML A205292 001 Jul 15, 2014RX RLD: A088811
BUDESONIDE
AEROSOL, FOAM;RECTAL
BUDESONIDE
PADAGIS ISRAEL 2MG/ACTUATION A215328 001 Apr 12, 2023RX RLD: N205613
BUPRENORPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPRENORPHINE HYDROCHLORIDE
ENDO OPERATIONS EQ 0.3MG BASE/ML A206586 001 Jul 28, 2015RX RLD: N018401
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
HIKMA EQ 8MG BASE;EQ 2MG BASE A203326 002 Jun 27, 2014RX RLD: N020733
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
APOTEX INC 100MG A076143 002 Jan 17, 2006RX RLD: N018644
CABERGOLINE
TABLET;ORAL
CABERGOLINE
INGENUS PHARMS LLC 0.5MG A204735 001 Aug 01, 2018RX RLD: N020664
Approved Drug Product List - Orange Book
Page 6 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
CAFFEINE; ERGOTAMINE TARTRATE
TABLET;ORAL
ERGOTAMINE TARTRATE AND CAFFEINE
MIKART 100MG;1MG A040590 001 Sep 16, 2005RX RLD: A084294
CALCIPOTRIENE
OINTMENT;TOPICAL
CALCIPOTRIENE
GLENMARK PHARMS
INC
0.005% A090633 001 Mar 24, 2010RX RLD: N020273
CALCITONIN SALMON
SPRAY, METERED;NASAL
CALCITONIN-SALMON
APOTEX INC 200 IU/SPRAY A076396 001 Nov 17, 2008RX RLD: N020313
CALCIUM ACETATE
CAPSULE;ORAL
CALCIUM ACETATE
INVAGEN PHARMS 667MG A203135 001 Feb 07, 2013RX RLD: N021160
CARBIDOPA; LEVODOPA
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
SCIEGEN PHARMS INC 50MG;200MG A214091 002 Oct 05, 2021RX RLD: N019856
CARBOPLATIN
INJECTABLE;INTRAVENOUS
CARBOPLATIN
ACCORD HLTHCARE 1GM/100ML (10MG/ML) A206775 005 Apr 06, 2020RX RLD: N020452
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
QILU EQ 10GM BASE/VIAL A209217 001 Oct 17, 2018RX RLD: N050461
CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFEPIME HYDROCHLORIDE
QILU EQ 500MG BASE/VIAL A203704 001 Feb 01, 2016RX RLD: N050679
EQ 1GM BASE/VIAL A203704 002 Feb 01, 2016RX RLD: N050679
EQ 2GM BASE/VIAL A203704 003 Feb 01, 2016RX RLD: N050679
POWDER;INTRAVENOUS
CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
SAMSON MEDCL EQ 100GM BASE A209408 001 Aug 21, 2018RX RLD: N050679
CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTETAN
FRESENIUS KABI USA EQ 1GM BASE/VIAL A065374 001 Aug 09, 2007RX RLD: N050588
EQ 2GM BASE/VIAL A065374 002 Aug 09, 2007RX RLD: N050588
CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME SODIUM
HIKMA EQ 1.5GM BASE/VIAL A065048 002 Jan 09, 2004RX RLD: N050558
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
HIKMA EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004RX RLD: N050558
CHLOROQUINE PHOSPHATE
TABLET;ORAL
CHLOROQUINE PHOSPHATE
NATCO PHARMA LTD 500MG A090612 001 Jan 21, 2011RX RLD: N006002
Approved Drug Product List - Orange Book
Page 7 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
CHLOROTHIAZIDE SODIUM
INJECTABLE;INJECTION
CHLOROTHIAZIDE SODIUM
SAGENT PHARMS INC EQ 500MG BASE/VIAL A202462 001 May 29, 2015RX RLD: N011145
CHLORPROMAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
CHLORPROMAZINE HYDROCHLORIDE
GENUS 30MG/ML A214542 001 Jun 02, 2021RX RLD: N009149
100MG/ML A214542 002 Jun 02, 2021RX RLD: N009149
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
MIKART 250MG A207483 001 Jun 24, 2016RX RLD: N011300
CIPROFLOXACIN
INJECTABLE;INJECTION
CIPROFLOXACIN
BAXTER HLTHCARE
CORP
200MG/20ML (10MG/ML) A078062 001 Apr 29, 2008RX RLD: N019847
400MG/40ML (10MG/ML) A078062 002 Apr 29, 2008RX RLD: N019847
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 200MG/100ML A077753 001 Mar 18, 2008RX RLD: N019857
400MG/200ML A077753 002 Mar 18, 2008RX RLD: N019857
CISATRACURIUM BESYLATE
INJECTABLE;INJECTION
CISATRACURIUM BESYLATE
MEITHEAL EQ 2MG BASE/ML A211668 001 Apr 25, 2019RX RLD: N020551
EQ 2MG BASE/ML A211669 001 Apr 25, 2019RX RLD: N020551
EQ 10MG BASE/ML A211668 002 Apr 25, 2019RX RLD: N020551
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
FOR SOLUTION;ORAL
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
HETERO LABS LTD V 12GM/PACKET;3.5GM/PACKET;10MG/P
ACKET
A212789 001 Jul 18, 2022RX RLD: N202535
CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM;TOPICAL
CLINDAMYCIN PHOSPHATE
PADAGIS ISRAEL 1% A090785 001 Mar 31, 2010RX RLD: N050801
INJECTABLE;INJECTION
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
SANDOZ INC EQ 6MG BASE/ML A201692 001 May 31, 2012RX RLD: N050639
EQ 12MG BASE/ML A201692 002 May 31, 2012RX RLD: N050639
EQ 18MG BASE/ML A201692 003 May 31, 2012RX RLD: N050639
CLOBETASOL PROPIONATE
AEROSOL, FOAM;TOPICAL
CLOBETASOL PROPIONATE
PADAGIS ISRAEL 0.05% A201402 001 Aug 14, 2012RX RLD: N022013
TARO 0.05% A208779 001 Oct 04, 2018RX RLD: N021142
CREAM;TOPICAL
CLOBETASOL PROPIONATE
ENCUBE 0.05% A212982 001 Aug 28, 2020RX RLD: N019322
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
FOUGERA PHARMS 0.05% A074407 001 Feb 23, 1996RX RLD: N019323
Approved Drug Product List - Orange Book
Page 8 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
CLONIDINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE HYDROCHLORIDE
AJANTA PHARMA LTD 0.1MG A209686 001 Nov 20, 2017RX RLD: N022331
COLCHICINE
TABLET;ORAL
COLCHICINE
ENDO OPERATIONS 0.6MG A203976 001 Aug 12, 2021RX RLD: N022352
CUPRIC SULFATE
INJECTABLE;INJECTION
CUPRIC SULFATE
AM REGENT EQ 0.4MG COPPER/ML A216324 001 Dec 16, 2022RX RLD: N019350
CYANOCOBALAMIN
SPRAY, METERED;NASAL
CYANOCOBALAMIN
PADAGIS ISRAEL 0.5MG/SPRAY A212458 001 Sep 09, 2020RX RLD: N021642
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
RUBICON 10MG A208170 003 May 31, 2017RX RLD: N017821
CYPROHEPTADINE HYDROCHLORIDE
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
ZYDUS PHARMS 4MG A208938 001 May 19, 2017RX RLD: N012649
CYTARABINE
INJECTABLE;INJECTION
CYTARABINE
FRESENIUS KABI USA 100MG/ML A076512 001 Jan 15, 2004RX RLD: N016793
HOSPIRA 20MG/ML A071868 001 Jun 04, 1990RX RLD: N016793
WEST-WARD PHARMS
INT
2GM/VIAL A074245 002 Aug 31, 1994RX RLD: N016793
DACARBAZINE
INJECTABLE;INJECTION
DACARBAZINE
FRESENIUS KABI USA 100MG/VIAL A075371 001 Aug 27, 1999RX RLD: N017575
200MG/VIAL A075371 002 Aug 27, 1999RX RLD: N017575
DACTINOMYCIN
INJECTABLE;INJECTION
DACTINOMYCIN
EUGIA PHARMA 0.5MG/VIAL A203385 001 Nov 09, 2017RX RLD: N050682
DAPSONE
TABLET;ORAL
DAPSONE
NOVITIUM PHARMA 100MG A206505 002 Dec 01, 2016RX RLD: A086842
DAPTOMYCIN
POWDER;INTRAVENOUS
DAPTOMYCIN
QILU PHARM HAINAN 500MG/VIAL A215316 001 Aug 24, 2021RX RLD: N021572
DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
DARIFENACIN
MACLEODS PHARMS
LTD
EQ 15MG BASE A207302 002 Jul 28, 2017RX RLD: N021513
Approved Drug Product List - Orange Book
Page 9 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
DECITABINE
INJECTABLE;INTRAVENOUS
DECITABINE
ACCORD HLTHCARE 50MG/VIAL A203475 001 Feb 27, 2017RX RLD: N021790
DEFERIPRONE
TABLET;ORAL
DEFERIPRONE
HIKMA 1GM A213239 002 Feb 08, 2022RX RLD: N021825
DESOGESTREL; ETHINYL ESTRADIOL
TABLET;ORAL-28
DESOGESTREL AND ETHINYL ESTRADIOL
DURAMED PHARMS
BARR
0.15MG;0.03MG A075256 002 Aug 12, 1999RX RLD: N020301
DESONIDE
GEL;TOPICAL
DESONIDE
CINTEX SVCS 0.05% A202470 001 May 11, 2020RX RLD: N021844
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
FRESENIUS KABI USA EQ 10MG PHOSPHATE/ML A040491 001 Apr 11, 2003RX RLD: N014694
DIAZEPAM
INJECTABLE;INJECTION
DIAZEPAM
BELOTECA 10MG/2ML (5MG/ML) A210363 001 Mar 18, 2019RX RLD: N016087
DICLOFENAC POTASSIUM
TABLET;ORAL
DICLOFENAC POTASSIUM
RK PHARMA 50MG A075463 001 Jul 26, 1999RX RLD: N020142
DICLOFENAC SODIUM
GEL;TOPICAL
DICLOFENAC SODIUM
TARO 3% A206298 001 Apr 28, 2016RX RLD: N021005
SOLUTION;TOPICAL
DICLOFENAC SODIUM
LUPIN PHARMS 2% A208021 001 Sep 20, 2022RX RLD: N204623
TABLET, EXTENDED RELEASE;ORAL
DICLOFENAC SODIUM
DEXCEL LTD 100MG A076201 001 Nov 06, 2002RX RLD: N020254
DICYCLOMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DICYCLOMINE HYDROCHLORIDE
FOSUN PHARMA 10MG/ML A210979 001 Jul 02, 2018RX RLD: N008370
SYRUP;ORAL
DICYCLOMINE HYDROCHLORIDE
ENDO OPERATIONS 10MG/5ML A040169 001 Mar 24, 2005RX RLD: N007961
DIHYDROERGOTAMINE MESYLATE
INJECTABLE;INJECTION
DIHYDROERGOTAMINE MESYLATE
HIKMA PHARMS 1MG/ML A206621 001 Sep 15, 2017RX RLD: N005929
DIMENHYDRINATE
INJECTABLE;INJECTION
DIMENHYDRINATE
FRESENIUS KABI USA 50MG/ML A040519 001 Jun 23, 2004RX RLD: A080615
Approved Drug Product List - Orange Book
Page 10 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
MICRO LABS EQ 2% BASE A204778 001 Nov 08, 2019RX RLD: N020408
DOXORUBICIN HYDROCHLORIDE
INJECTABLE, LIPOSOMAL;INJECTION
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
SUN PHARM 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013RX RLD: N050718
50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013RX RLD: N050718
DOXYCYCLINE HYCLATE
INJECTABLE;INJECTION
DOXYCYCLINE
ZYDUS PHARMS EQ 100MG BASE/VIAL A207757 001 Sep 28, 2017RX RLD: N050442
TABLET, DELAYED RELEASE;ORAL
DOXYCYCLINE HYCLATE
HERITAGE PHARMS EQ 200MG BASE A200856 004 Nov 13, 2018RX RLD: N050795
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
AM REGENT 2.5MG/ML A072123 001 Oct 24, 1988RX RLD: N016796
DYCLONINE HYDROCHLORIDE
SOLUTION;TOPICAL
DYCLOPRO
SEPTODONT 0.5% A200480 001 Nov 20, 2018RX RLD: N009925
1% A200480 002 Nov 20, 2018RX RLD: N009925
EDETATE CALCIUM DISODIUM
INJECTABLE;INJECTION
EDETATE CALCIUM DISODIUM
CASPER PHARMA LLC 200MG/ML A216435 001 May 03, 2023RX RLD: N008922
EFAVIRENZ
CAPSULE;ORAL
EFAVIRENZ
AUROBINDO PHARMA 200MG A078064 003 Dec 15, 2017RX RLD: N020972
TABLET;ORAL
EFAVIRENZ
HETERO LABS LTD
III
600MG A078886 001 Apr 27, 2018RX RLD: N021360
EPOPROSTENOL SODIUM
INJECTABLE;INJECTION
EPOPROSTENOL SODIUM
SUN PHARM EQ 0.5MG BASE/VIAL A210473 001 Jan 15, 2021RX RLD: N022260
EPTIFIBATIDE
INJECTABLE;INJECTION
EPTIFIBATIDE
MYLAN LABS LTD 2MG/ML A203258 001 Jul 20, 2018RX RLD: N020718
75MG/100ML A203258 002 Jul 20, 2018RX RLD: N020718
ERGOCALCIFEROL
CAPSULE;ORAL
ERGOCALCIFEROL
STRIDES PHARMA 50,000 IU A090455 001 Aug 03, 2010RX RLD: N003444
ERLOTINIB HYDROCHLORIDE
TABLET;ORAL
ERLOTINIB HYDROCHLORIDE
ZYDUS PHARMS EQ 150MG BASE A213065 003 Apr 16, 2020RX RLD: N021743
Approved Drug Product List - Orange Book
Page 11 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
TABLET, DELAYED RELEASE;ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
DR REDDYS EQ 20MG BASE;500MG A204206 002 Feb 18, 2020RX RLD: N022511
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS
ESOMEPRAZOLE SODIUM
GLAND PHARMA LTD EQ 20MG BASE/VIAL A203349 001 Apr 01, 2020RX RLD: N021689
ESTRADIOL
TABLET;ORAL
ESTRADIOL
BARR LABS INC 2MG A040197 003 Oct 22, 1997RX RLD: A084500
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-28
BALZIVA-28
BARR 0.035MG;0.4MG A076238 001 Apr 22, 2004RX RLD: N017716
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET;ORAL
HAILEY 24 FE
GLENMARK PHARMS
LTD
0.02MG;1MG A204847 001 Nov 17, 2017RX RLD: N021871
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
GLENMARK PHARMS
LTD
0.02MG;1MG A210369 001 Dec 26, 2017RX RLD: N203667
TABLET;ORAL-28
CHABELINA FE
NOVAST LABS 0.02MG,0.03MG,0.035MG;1MG,1MG,1
MG
A202962 001 Apr 15, 2020RX RLD: N020130
ETHINYL ESTRADIOL; NORGESTIMATE
TABLET;ORAL-28
NORGESTIMATE AND ETHINYL ESTRADIOL
GLENMARK SPECLT 0.025MG,0.025MG,0.025MG;0.18MG,
0.215MG,0.25MG
A204057 001 Feb 23, 2016RX RLD: N021241
FAMCICLOVIR
TABLET;ORAL
FAMCICLOVIR
TEVA PHARMS 500MG A077487 003 Aug 24, 2007RX RLD: N020363
FAMOTIDINE
FOR SUSPENSION;ORAL
FAMOTIDINE
NOVITIUM PHARMA 40MG/5ML A215043 001 Apr 20, 2021RX RLD: N019527
TABLET;ORAL
FAMOTIDINE
AUROBINDO PHARMA
LTD
40MG A206530 002 Dec 22, 2015RX RLD: N019462
FAMOTIDINE; IBUPROFEN
TABLET;ORAL
IBUPROFEN AND FAMOTIDINE
ALKEM LABS LTD 26.6MG;800MG A211890 001 Aug 03, 2021RX RLD: N022519
FENOFIBRATE
CAPSULE;ORAL
FENOFIBRATE (MICRONIZED)
AJANTA PHARMA LTD 200MG A210705 003 Sep 10, 2018RX RLD: N019304
TABLET;ORAL
FENOFIBRATE
AUROBINDO PHARMA 145MG A205118 002 May 05, 2016RX RLD: N021656
MYLAN PHARMS INC 120MG A204475 002 Jun 23, 2016RX RLD: N022118
Approved Drug Product List - Orange Book
Page 12 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
FENOPROFEN CALCIUM
CAPSULE;ORAL
FENOPROFEN CALCIUM
RISING EQ 400MG BASE A214475 001 Jul 18, 2022RX RLD: N017604
FLUCONAZOLE
INJECTABLE;INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INFORLIFE 200MG/100ML (2MG/ML) A079104 001 Jul 30, 2009RX RLD: N019950
400MG/200ML (2MG/ML) A079104 002 Jul 30, 2009RX RLD: N019950
FLUDEOXYGLUCOSE F-18
INJECTABLE;INTRAVENOUS
FLUDEOXYGLUCOSE F18
CARDINAL HEALTH
414
20-500mCi/ML A203603 002 Sep 27, 2018RX RLD: N021870
FLUNISOLIDE
SPRAY, METERED;NASAL
FLUNISOLIDE
BAUSCH 0.025MG/SPRAY A074805 001 Feb 20, 2002RX RLD: N018148
FLUOCINONIDE
CREAM;TOPICAL
FLUOCINONIDE
AMNEAL 0.05% A210554 001 Aug 21, 2018RX RLD: N019117
FLUOROURACIL
SOLUTION;TOPICAL
FLUOROURACIL
TARO 5% A076526 002 Nov 05, 2003RX RLD: N016831
FLUOXETINE HYDROCHLORIDE
TABLET;ORAL
FLUOXETINE HYDROCHLORIDE
DR REDDYS EQ 20MG BASE A076006 002 Apr 23, 2018RX RLD: N020974
TORRENT EQ 20MG BASE A206937 002 Oct 21, 2016RX RLD: N021860
FLURANDRENOLIDE
LOTION;TOPICAL
FLURANDRENOLIDE
PADAGIS ISRAEL 0.05% A207133 001 Aug 30, 2016RX RLD: N013790
OINTMENT;TOPICAL
FLURANDRENOLIDE
TELIGENT 0.05% A207851 001 Dec 30, 2016RX RLD: N012806
FLURBIPROFEN
TABLET;ORAL
FLURBIPROFEN
TEVA 100MG A074431 001 May 31, 1995RX RLD: N018766
FLUTICASONE PROPIONATE
SPRAY, METERED;NASAL
FLUTICASONE PROPIONATE
HIKMA 0.05MG/SPRAY A076504 001 Feb 22, 2006RX RLD: N020121
0.05MG/SPRAY A207957 001 May 26, 2016OTC RLD: N205434
FOLIC ACID
TABLET;ORAL
FOLIC ACID
AMNEAL PHARM 1MG A040625 001 Jul 21, 2005RX RLD: A080680
Approved Drug Product List - Orange Book
Page 13 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
FOSAMPRENAVIR CALCIUM
TABLET;ORAL
FOSAMPRENAVIR CALCIUM
MYLAN EQ 700MG BASE A204060 001 Apr 15, 2016RX RLD: N021548
GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE;ORAL
GALANTAMINE HYDROBROMIDE
AUROBINDO PHARMA EQ 8MG BASE A204895 001 Aug 05, 2016RX RLD: N021615
GANCICLOVIR SODIUM
INJECTABLE;INJECTION
GANCICLOVIR SODIUM
PHARMASCIENCE INC EQ 500MG BASE/VIAL A207645 001 Dec 08, 2017RX RLD: N019661
GLUCAGON
INJECTABLE;INJECTION
GLUCAGON
AMPHASTAR PHARMS
INC
1MG/VIAL A208086 001 Dec 28, 2020RX RLD: N020928
GLYBURIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDE
AUROBINDO PHARMA 2.5MG;500MG A077870 002 Nov 14, 2007RX RLD: N021178
GLYCOPYRROLATE
INJECTABLE;INJECTION
GLYCOPYRROLATE
HIKMA FARMACEUTICA 0.2MG/ML A090963 001 Sep 21, 2011RX RLD: N017558
TABLET;ORAL
GLYCOPYRROLATE
LGM PHARMA 1.5MG A091522 001 Mar 12, 2012RX RLD: N012827
GRANISETRON HYDROCHLORIDE
TABLET;ORAL
GRANISETRON HYDROCHLORIDE
ORBION PHARMS EQ 1MG BASE A078678 001 Feb 13, 2008RX RLD: N020305
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
SYRUP;ORAL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ABHAI LLC 1.5MG/5ML;5MG/5ML A207487 001 Feb 21, 2017RX RLD: N005213
TABLET;ORAL
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
AVANTHI INC 1.5MG;5MG A207176 001 Aug 07, 2017RX RLD: N005213
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDRA-ZIDE
STRIDES PHARMA 50MG;50MG A088946 001 Oct 21, 1985RX RLD: A084810
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
INVAGEN PHARMS 12.5MG;20MG A204058 002 May 23, 2017RX RLD: N019888
25MG;20MG A204058 003 May 23, 2017RX RLD: N019888
HYDROCODONE BITARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
HYDROCODONE BITARTRATE
ALVOGEN 10MG A206986 001 Jan 21, 2020RX RLD: N202880
Approved Drug Product List - Orange Book
Page 14 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
HYDROCODONE BITARTRATE; IBUPROFEN
TABLET;ORAL
HYDROCODONE BITARTRATE AND IBUPROFEN
AMNEAL PHARMS NY 7.5MG;200MG A076642 001 Oct 12, 2004RX RLD: N020716
HYDROCORTISONE
CREAM;TOPICAL
HYDROCORTISONE
FOUGERA PHARMS INC 2.5% A089414 001 Dec 16, 1986RX RLD: A087457
HYDROMORPHONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
HYDROMORPHONE HYDROCHLORIDE
OSMOTICA PHARM US 32MG A205629 004 Jul 07, 2016RX RLD: N021217
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
HYDROXYCHLOROQUINE SULFATE
ACCORD HLTHCARE 400MG A213342 004 Aug 18, 2021RX RLD: N009768
APPCO 100MG A210441 002 Sep 19, 2022RX RLD: N009768
IBANDRONATE SODIUM
TABLET;ORAL
IBANDRONATE SODIUM
DR REDDYS LABS LTD EQ 150MG BASE A078997 001 Apr 30, 2012RX RLD: N021455
IMIPRAMINE PAMOATE
CAPSULE;ORAL
IMIPRAMINE PAMOATE
HIKMA EQ 75MG HYDROCHLORIDE A091099 001 Apr 16, 2010RX RLD: N017090
IMIQUIMOD
CREAM;TOPICAL
IMIQUIMOD
GLENMARK PHARMS
INC
5% A201994 001 Mar 06, 2012RX RLD: N020723
INDOMETHACIN SODIUM
INJECTABLE;INJECTION
INDOMETHACIN SODIUM
NAVINTA LLC EQ 1MG BASE/VIAL A206561 001 Jul 19, 2017RX RLD: N018878
IPRATROPIUM BROMIDE
SPRAY, METERED;NASAL
IPRATROPIUM BROMIDE
HIKMA 0.021MG/SPRAY A076664 001 Nov 05, 2003RX RLD: N020393
0.042MG/SPRAY A076598 001 Nov 05, 2003RX RLD: N020394
ISOPROTERENOL HYDROCHLORIDE
INJECTABLE;INJECTION
ISOPROTERENOL HYDROCHLORIDE
NEXUS 0.2MG/ML A206961 001 Aug 02, 2017RX RLD: N010515
ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE;ORAL
ISOSORBIDE MONONITRATE
RICONPHARMA LLC 120MG A210918 003 Nov 05, 2018RX RLD: N020225
ISOSULFAN BLUE
SOLUTION;SUBCUTANEOUS
ISOSULFAN BLUE
MYLAN
INSTITUTIONAL
50MG/5ML (10MG/ML) A090874 001 Jul 20, 2010RX RLD: N018310
Approved Drug Product List - Orange Book
Page 15 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
ISRADIPINE
CAPSULE;ORAL
ISRADIPINE
WATSON LABS TEVA 5MG A077317 002 Jan 05, 2006RX RLD: N019546
KETOCONAZOLE
AEROSOL, FOAM;TOPICAL
KETOCONAZOLE
XIROMED 2% A213601 001 May 21, 2021RX RLD: N021738
KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
ZADITOR
ALCON PHARMS LTD EQ 0.025% BASE A077200 001 Sep 02, 2008OTC RLD: N021066
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
HOSPIRA 5MG/ML A075239 001 Nov 29, 1999RX RLD: N018686
TABLET;ORAL
LABETALOL HYDROCHLORIDE
SANDOZ 200MG A075113 002 Aug 04, 1998RX RLD: N018687
LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
LAMIVUDINE AND ZIDOVUDINE
HETERO LABS LTD
III
150MG;300MG A079124 001 Sep 17, 2015RX RLD: N020857
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
FRESENIUS KABI USA EQ 10MG BASE/ML A207226 001 Jul 27, 2018RX RLD: N008107
EQ 10MG BASE/ML A207241 001 Mar 14, 2018RX RLD: N008107
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLET;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
GLENMARK PHARMS
LTD
5MG A090385 001 Feb 24, 2011RX RLD: N022064
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
INFORLIFE EQ 250MG/50ML (EQ 5MG/ML) A090343 001 Jul 07, 2011RX RLD: N020635
EQ 500MG/100ML (EQ 5MG/ML) A090343 002 Jul 07, 2011RX RLD: N020635
EQ 750MG/150ML (EQ 5MG/ML) A090343 003 Jul 07, 2011RX RLD: N020635
SOLUTION;ORAL
LEVOFLOXACIN
NOVITIUM PHARMA 250MG/10ML A091678 001 Jun 20, 2011RX RLD: N021721
LEVOLEUCOVORIN CALCIUM
SOLUTION;INTRAVENOUS
LEVOLEUCOVORIN CALCIUM
GLAND PHARMA LTD EQ 250MG BASE/25ML (EQ 10MG
BASE/ML)
A210892 002 Sep 14, 2018RX RLD: N020140
MEITHEAL EQ 175MG BASE/17.5ML (EQ 10MG
BASE/ML)
A211002 001 Aug 16, 2019RX RLD: N020140
LEVORPHANOL TARTRATE
TABLET;ORAL
LEVORPHANOL TARTRATE
NOVITIUM PHARMA 3MG A213479 002 Jan 12, 2021RX RLD: N008720
Approved Drug Product List - Orange Book
Page 16 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
LIDOCAINE HYDROCHLORIDE
SOLUTION;ORAL
LIDOCAINE HYDROCHLORIDE
RUBICON 2% A216780 001 Mar 28, 2023RX RLD: N009470
SOLUTION;TOPICAL
LIDOCAINE HYDROCHLORIDE
HIKMA 4% A088803 001 Apr 03, 1985RX RLD: N010417
LIDOCAINE; PRILOCAINE
CREAM;TOPICAL
LIDOCAINE AND PRILOCAINE
FOUGERA PHARMS 2.5%;2.5% A076453 001 Aug 18, 2003RX RLD: N019941
LITHIUM CITRATE
SYRUP;ORAL
LITHIUM CITRATE
RUBICON EQ 300MG CARBONATE/5ML A218036 001 Aug 14, 2023RX RLD: N018421
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
MYLAN 2MG A072741 001 Sep 18, 1991RX RLD: N017694
MEFLOQUINE HYDROCHLORIDE
TABLET;ORAL
MEFLOQUINE HYDROCHLORIDE
BARR 250MG A076392 001 Dec 29, 2003RX RLD: N019591
MELOXICAM
CAPSULE;ORAL
MELOXICAM
LUPIN LTD 10MG A209487 002 Jun 01, 2020RX RLD: N207233
MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
MEMANTINE HYDROCHLORIDE
ZYDUS PHARMS 28MG A203293 004 Aug 03, 2017RX RLD: N022525
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
WEST-WARD PHARMS
INT
10MG/ML A081002 001 Jul 30, 1993RX RLD: A088432
TABLET;ORAL
MEPERIDINE HYDROCHLORIDE
EPIC PHARMA LLC 50MG A040331 001 May 28, 1999RX RLD: N005010
MEPROBAMATE
TABLET;ORAL
MEPROBAMATE
ALEMBIC PHARMS LTD 200MG A090122 001 Feb 18, 2009RX RLD: A083304
400MG A090122 002 Feb 18, 2009RX RLD: A083308
MESALAMINE
TABLET, DELAYED RELEASE;ORAL
MESALAMINE
ZYDUS PHARMS 800MG A203286 001 Jul 21, 2017RX RLD: N021830
METAXALONE
TABLET;ORAL
METAXALONE
AMNEAL PHARMS 800MG A203399 001 Jun 21, 2013RX RLD: N013217
Approved Drug Product List - Orange Book
Page 17 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
METFORMIN HYDROCHLORIDE
SOLUTION;ORAL
METFORMIN HYDROCHLORIDE
SAPTALIS PHARMS 500MG/5ML A211309 001 Mar 03, 2020RX RLD: N021591
TABLET, EXTENDED RELEASE;ORAL
METFORMIN HYDROCHLORIDE
ALKEM LABS LTD 750MG A206145 002 Oct 22, 2018RX RLD: N021202
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
DR REDDYS LABS SA 1GM;EQ 5MG BASE A207678 003 Aug 09, 2023RX RLD: N200678
METHADONE HYDROCHLORIDE
TABLET;ORAL
METHADONE HYDROCHLORIDE
SPECGX LLC 5MG A040517 001 Apr 27, 2004RX RLD: N006134
10MG A040517 002 Apr 27, 2004RX RLD: N006134
METHENAMINE HIPPURATE
TABLET;ORAL
METHENAMINE HIPPURATE
AUROBINDO PHARMA
LTD
1GM A205661 001 Jul 05, 2016RX RLD: N017681
METHOCARBAMOL
TABLET;ORAL
METHOCARBAMOL
GRANULES 500MG A209312 001 May 07, 2018RX RLD: N011011
750MG A209312 002 May 07, 2018RX RLD: N011011
HANGZHOU BINJIANG 1GM A200958 003 Dec 06, 2021RX RLD: N011011
METHOTREXATE SODIUM
INJECTABLE;INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREE
ACCORD HLTHCARE EQ 250MG BASE/10ML (EQ 25MG
BASE/ML)
A040768 001 Apr 30, 2007RX RLD: A088760
TABLET;ORAL
METHOTREXATE SODIUM
HIKMA EQ 2.5MG BASE A040054 001 Aug 01, 1994RX RLD: N008085
METHYLERGONOVINE MALEATE
TABLET;ORAL
METHYLERGONOVINE MALEATE
CHARTWELL RX 0.2MG A091577 001 May 02, 2011RX RLD: N006035
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
METHYLPHENIDATE HYDROCHLORIDE
DR REDDYS LABS SA 60MG A078458 004 Jun 23, 2016RX RLD: N021284
TABLET, CHEWABLE;ORAL
METHYLPHENIDATE HYDROCHLORIDE
ASCENT PHARMS INC 10MG A210354 003 Dec 29, 2017RX RLD: N021475
TABLET, EXTENDED RELEASE;ORAL
METHYLPHENIDATE HYDROCHLORIDE
OSMOTICA PHARM US 72MG A205327 005 Jul 28, 2017RX RLD: N021121
METHYLPREDNISOLONE ACETATE
INJECTABLE;INJECTION
METHYLPREDNISOLONE ACETATE
AMNEAL 40MG/ML A210043 001 May 20, 2019RX RLD: N011757
80MG/ML A210043 002 May 20, 2019RX RLD: N011757
SAGENT PHARMS INC 40MG/ML A201835 002 Jun 27, 2018RX RLD: N011757
80MG/ML A201835 003 Jun 27, 2018RX RLD: N011757
Approved Drug Product List - Orange Book
Page 18 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
METHYLTESTOSTERONE
CAPSULE;ORAL
METHYLTESTOSTERONE
IMPAX LABS INC 10MG A204851 001 Sep 21, 2015RX RLD: A083976
METOPROLOL TARTRATE
TABLET;ORAL
METOPROLOL TARTRATE
MYLAN 100MG A076704 003 Jan 16, 2004RX RLD: N017963
METRONIDAZOLE
GEL;TOPICAL
METRONIDAZOLE
COSETTE 0.75% A078178 001 Jan 19, 2011RX RLD: N019737
TABLET;ORAL
METRONIDAZOLE
AUROBINDO PHARMA
LTD
500MG A203974 002 May 29, 2015RX RLD: N012623
MINOCYCLINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
ALKEM LABS LTD EQ 115MG BASE A204453 007 Mar 16, 2018RX RLD: N050808
EQ 135MG BASE A204453 005 Sep 28, 2016RX RLD: N050808
MOMETASONE FUROATE
SPRAY, METERED;NASAL
MOMETASONE FUROATE
APOTEX 0.05MG/SPRAY A091161 001 Mar 22, 2016RX RLD: N020762
MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
MORPHINE SULFATE
UPSHER SMITH LABS 10MG A202104 001 Jun 03, 2013RX RLD: N020616
100MG A202104 007 Jun 03, 2013RX RLD: N020616
MOXIFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
MOXIFLOXACIN HYDROCHLORIDE
LUPIN LTD EQ 0.5% BASE A204079 001 May 28, 2015RX RLD: N022428
SOLUTION;INTRAVENOUS
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
MYLAN LABS LTD 400MG/250ML (1.6MG/ML) A205833 001 May 05, 2017RX RLD: N021277
NAFTIFINE HYDROCHLORIDE
CREAM;TOPICAL
NAFTIFINE HYDROCHLORIDE
TARO 1% A205975 001 Sep 08, 2016RX RLD: N019599
NALMEFENE HYDROCHLORIDE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
NALMEFENE HYDROCHLORIDE
CHENGDU SHUODE EQ 0.1MG BASE/ML (EQ 0.1MG
BASE/ML)
A216007 001 Nov 15, 2023RX RLD: N020459
PURDUE PHARMA LP EQ 2MG BASE/2ML (EQ 1MG
BASE/ML)
A212955 001 Feb 08, 2022RX RLD: N020459
NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
SPECGX LLC 50MG A076264 002 Mar 22, 2002RX RLD: N018932
Approved Drug Product List - Orange Book
Page 19 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
NARATRIPTAN HYDROCHLORIDE
TABLET;ORAL
NARATRIPTAN
HERITAGE PHARMS EQ 2.5MG BASE A200502 002 Feb 28, 2011RX RLD: N020763
NATEGLINIDE
TABLET;ORAL
NATEGLINIDE
ZYDUS PHARMS 120MG A205248 002 Jul 06, 2016RX RLD: N021204
NEVIRAPINE
TABLET, EXTENDED RELEASE;ORAL
NEVIRAPINE
MACLEODS PHARMS
LTD
400MG A206879 001 Oct 06, 2017RX RLD: N201152
TABLET;ORAL
NEVIRAPINE
MACLEODS PHARMS
LTD
200MG A090688 001 Jan 14, 2019RX RLD: N020636
NIACIN
TABLET;ORAL
NIACOR
AVONDALE PHARMS 500MG A040378 001 May 03, 2000RX RLD: A083823
NICARDIPINE HYDROCHLORIDE
CAPSULE;ORAL
NICARDIPINE HYDROCHLORIDE
EPIC PHARMA LLC 30MG A074928 002 Mar 19, 1998RX RLD: N019488
NIFEDIPINE
TABLET, EXTENDED RELEASE;ORAL
NIFEDIPINE
NOVAST LABS 60MG A202987 002 Aug 25, 2016RX RLD: N020198
90MG A202987 003 Aug 25, 2016RX RLD: N020198
NITRIC OXIDE
GAS;INHALATION
NOXIVENT
LINDE GAS EQUIP 100PPM A207141 001 Oct 02, 2018RX RLD: N020845
NORTRIPTYLINE HYDROCHLORIDE
SOLUTION;ORAL
NORTRIPTYLINE HYDROCHLORIDE
PHARM ASSOC EQ 10MG BASE/5ML A075606 001 Aug 23, 2000RX RLD: N014685
NYSTATIN
SUSPENSION;ORAL
NYSTATIN
LEADING 100,000 UNITS/ML A214346 001 Mar 10, 2022RX RLD: N050299
OFLOXACIN
SOLUTION/DROPS;OTIC
OFLOXACIN
BAUSCH AND LOMB 0.3% A076128 001 Mar 17, 2008RX RLD: N020799
OLOPATADINE HYDROCHLORIDE
SPRAY, METERED;NASAL
OLOPATADINE HYDROCHLORIDE
AMNEAL 0.665MG/SPRAY A210901 001 Jan 28, 2020RX RLD: N021861
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
OMEPRAZOLE
SANDOZ 20MG A075757 002 Jan 28, 2003RX RLD: N019810
40MG A076515 001 Jan 21, 2009RX RLD: N019810
Approved Drug Product List - Orange Book
Page 20 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
AJANTA PHARMA LTD 40MG;1.1GM A204228 002 Jul 15, 2016RX RLD: N021849
FOR SUSPENSION;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
AJANTA PHARMA LTD 40MG/PACKET;1.68GM/PACKET A205545 002 Jul 27, 2016RX RLD: N021636
ONDANSETRON
TABLET, ORALLY DISINTEGRATING;ORAL
ONDANSETRON
CHARTWELL
MOLECULES
16MG A077406 001 Dec 26, 2006RX RLD: N020781
24MG A077406 002 Dec 26, 2006RX RLD: N020781
ONDANSETRON HYDROCHLORIDE
SOLUTION;ORAL
ONDANSETRON HYDROCHLORIDE
HIKMA EQ 4MG BASE/5ML A076960 001 Dec 26, 2006RX RLD: N020605
OXALIPLATIN
INJECTABLE;INTRAVENOUS
OXALIPLATIN
GLAND 50MG/10ML (5MG/ML) A207325 001 Feb 10, 2017RX RLD: N021759
100MG/20ML (5MG/ML) A207325 002 Feb 10, 2017RX RLD: N021759
QILU PHARM HAINAN 200MG/40ML (5MG/ML) A204368 003 Jun 07, 2016RX RLD: N021759
OXYBUTYNIN CHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OXYBUTYNIN CHLORIDE
ACCORD HLTHCARE 15MG A207138 003 Feb 29, 2016RX RLD: N020897
TABLET;ORAL
OXYBUTYNIN CHLORIDE
RISING 2.5MG A209025 002 Feb 07, 2023RX RLD: N017577
PALONOSETRON HYDROCHLORIDE
INJECTABLE;INTRAVENOUS
PALONOSETRON HYDROCHLORIDE
AVET LIFESCIENCES EQ 0.075MG BASE/1.5ML (EQ
0.05MG BASE/ML)
A202951 001 Jun 29, 2021RX RLD: N021372
DR REDDYS EQ 0.25MG BASE/5ML (EQ 0.05MG
BASE/ML)
A201533 002 Apr 21, 2016RX RLD: N021372
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
DR REDDYS 1MG/ML A072759 001 Jul 31, 1990RX RLD: N017015
2MG/ML A072760 001 Jul 31, 1990RX RLD: N017015
PARICALCITOL
CAPSULE;ORAL
PARICALCITOL
TEVA PHARMS USA 4MCG A090829 003 Sep 27, 2013RX RLD: N021606
PEMETREXED DISODIUM
POWDER;INTRAVENOUS
PEMETREXED DISODIUM
FRESENIUS KABI USA EQ 750MG BASE/VIAL A090384 003 May 25, 2022RX RLD: N021462
EQ 1GM BASE/VIAL A090384 004 May 25, 2022RX RLD: N021462
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
APOTEX 400MG A075191 001 Jun 09, 1999RX RLD: N018631
Approved Drug Product List - Orange Book
Page 21 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE;ORAL
PHENOXYBENZAMINE HYDROCHLORIDE
ENDO OPERATIONS 10MG A204522 001 Jan 24, 2017RX RLD: N008708
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
PHENTERMINE HYDROCHLORIDE
NUVO PHARM 37.5MG A205017 001 Sep 25, 2014RX RLD: A088023
TABLET;ORAL
LOMAIRA
AVANTHI INC 8MG A203495 001 Sep 12, 2016RX RLD: N012737
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
PHENYLEPHRINE HYDROCHLORIDE
MANKIND PHARMA 2.5% A216859 001 Sep 29, 2022RX RLD: N207926
10% A216496 001 Jan 11, 2023RX RLD: N207926
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
GENUS 5MG/5ML;6.25MG/5ML A040654 001 Dec 07, 2006RX RLD: A088761
PHYTONADIONE
INJECTABLE;INJECTION
PHYTONADIONE
CIPLA 1MG/0.5ML A214596 001 Apr 22, 2022RX RLD: N012223
10MG/ML A214596 002 Apr 22, 2022RX RLD: N012223
TABLET;ORAL
PHYTONADIONE
ZYDUS LIFESCIENCES 5MG A210189 001 Feb 20, 2019RX RLD: N010104
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
INJECTABLE;INJECTION
PIPERACILLIN AND TAZOBACTAM
WOCKHARDT BIO AG EQ 2GM BASE/VIAL;EQ 250MG
BASE/VIAL
A206996 001 Mar 22, 2017RX RLD: N050684
EQ 3GM BASE/VIAL;EQ 375MG
BASE/VIAL
A206996 002 Mar 22, 2017RX RLD: N050684
EQ 4GM BASE/VIAL;EQ 500MG
BASE/VIAL
A206996 003 Mar 22, 2017RX RLD: N050684
EQ 36GM BASE/VIAL;EQ 4.5GM
BASE/VIAL
A207146 001 Mar 17, 2017RX RLD: N050684
POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE;ORAL
KLOR-CON M20
UPSHER SMITH LABS 20MEQ A074726 001 Nov 20, 1998RX RLD: N019439
POTASSIUM CHLORIDE
TWI PHARMS 20MEQ A209688 002 Jan 12, 2018RX RLD: N018279
PRAZIQUANTEL
TABLET;ORAL
PRAZIQUANTEL
ENDO OPERATIONS 600MG A208820 001 Nov 27, 2017RX RLD: N018714
PREDNISOLONE SODIUM PHOSPHATE
SOLUTION/DROPS;OPHTHALMIC
PREDNISOLONE SODIUM PHOSPHATE
BAUSCH AND LOMB EQ 0.9% PHOSPHATE A040070 001 Jul 29, 1994RX RLD: A080751
SOLUTION;ORAL
PREDNISOLONE SODIUM PHOSPHATE
PHARM ASSOC EQ 15MG BASE/5ML A076913 001 Apr 25, 2005RX RLD: N019157
Approved Drug Product List - Orange Book
Page 22 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
PRILOCAINE HYDROCHLORIDE
SEPTODONT INC 4% A079235 001 Sep 29, 2010RX RLD: N021382
PROGESTERONE
INJECTABLE;INJECTION
PROGESTERONE
EUGIA PHARMA 50MG/ML A210965 001 Dec 06, 2018RX RLD: N017362
PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PROPAFENONE HYDROCHLORIDE
STRIDES PHARMA 425MG A078540 003 Oct 18, 2010RX RLD: N021416
PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
PROPARACAINE HYDROCHLORIDE
BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995RX RLD: N008883
PYRAZINAMIDE
TABLET;ORAL
PYRAZINAMIDE
HIKMA 500MG A081319 001 Jun 30, 1992RX RLD: A080157
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
LUPIN EQ 40MG BASE A077690 004 Jun 20, 2006RX RLD: N019885
RANOLAZINE
TABLET, EXTENDED RELEASE;ORAL
RANOLAZINE
SUN PHARM 1GM A211707 002 May 28, 2019RX RLD: N021526
RILUZOLE
TABLET;ORAL
RILUZOLE
ALKEM LABS LTD 50MG A204048 001 Mar 30, 2016RX RLD: N020599
SAXAGLIPTIN HYDROCHLORIDE
TABLET;ORAL
SAXAGLIPTIN
MYLAN EQ 5MG BASE A205980 002 Jul 31, 2023RX RLD: N022350
SELEGILINE HYDROCHLORIDE
CAPSULE;ORAL
SELEGILINE HYDROCHLORIDE
APOTEX 5MG A075321 001 Dec 04, 1998RX RLD: N020647
SODIUM ACETATE
SOLUTION;INTRAVENOUS
SODIUM ACETATE
FRESENIUS KABI USA 400MEQ/100ML (4MEQ/ML) A206687 001 Oct 30, 2017RX RLD: N018893
SODIUM BENZOATE; SODIUM PHENYLACETATE
SOLUTION;INTRAVENOUS
SODIUM PHENYLACETATE AND SODIUM BENZOATE
AILEX PHARMS LLC 10%;10% (5GM/50ML;5GM/50ML) A207096 001 Feb 24, 2016RX RLD: N020645
SODIUM BICARBONATE
INJECTABLE;INJECTION
SODIUM BICARBONATE
EXELA PHARMA 0.5MEQ/ML A211091 001 Jun 20, 2019RX RLD: N019443
0.9MEQ/ML A211091 002 Jun 20, 2019RX RLD: N019443
1MEQ/ML A211091 003 Jun 20, 2019RX RLD: N019443
Approved Drug Product List - Orange Book
Page 23 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
SODIUM CHLORIDE
SOLUTION;INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
TARO 45MG/5ML (9MG/ML) A077407 001 Aug 11, 2006RX RLD: N019217
90MG/10ML (9MG/ML) A077407 002 Aug 11, 2006RX RLD: N019217
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
INJECTABLE;INJECTION
SODIUM PHOSPHATES
FRESENIUS KABI USA 142MG/ML;276MG/ML A209997 001 Mar 30, 2022RX RLD: N018892
SODIUM POLYSTYRENE SULFONATE
POWDER;ORAL, RECTAL
KALEXATE
KVK TECH 454GM/BOT A040905 001 Mar 30, 2009RX RLD: N011287
STERILE WATER FOR INJECTION
LIQUID;N/A
STERILE WATER FOR INJECTION
MEDEFIL INC 100% (2.5ML) A211188 002 Dec 02, 2019RX RLD: N018801
100% (3ML) A211188 003 Dec 02, 2019RX RLD: N018801
100% (5ML) A211188 004 Dec 02, 2019RX RLD: N018801
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
SUCCINYLCHOLINE CHLORIDE
ZYDUS PHARMS 20MG/ML A209467 001 May 04, 2018RX RLD: N008845
SULFADIAZINE
TABLET;ORAL
SULFADIAZINE
EPIC PHARMA LLC 500MG A040091 001 Jul 29, 1994RX RLD: N004122
SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE;INJECTION
SULFAMETHOXAZOLE AND TRIMETHOPRIM
MYLAN LABS LTD 80MG/ML;16MG/ML A206607 001 Aug 30, 2017RX RLD: N018374
TAVABOROLE
SOLUTION;TOPICAL
TAVABOROLE
ENCUBE 5% A211297 001 Oct 13, 2020RX RLD: N204427
TEMOZOLOMIDE
CAPSULE;ORAL
TEMOZOLOMIDE
ACCORD HLTHCARE 250MG A201528 006 Feb 27, 2017RX RLD: N021029
TERBUTALINE SULFATE
TABLET;ORAL
TERBUTALINE SULFATE
LANNETT CO INC 5MG A077152 002 Mar 25, 2005RX RLD: N017849
TERCONAZOLE
CREAM;VAGINAL
TERCONAZOLE
TARO 0.8% A075953 001 Apr 06, 2004RX RLD: N019964
TESTOSTERONE
GEL, METERED;TRANSDERMAL
TESTOSTERONE
ACTAVIS LABS UT
INC
10MG/0.5GM ACTUATION A204571 001 Aug 05, 2015RX RLD: N021463
12.5MG/1.25GM ACTUATION A076737 003 Mar 09, 2015RX RLD: N021015
Approved Drug Product List - Orange Book
Page 24 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
GEL;TRANSDERMAL
TESTOSTERONE
PADAGIS ISRAEL 1.62% (40.5MG/2.5GM PACKET) A205781 002 Jul 12, 2017RX RLD: N022309
SOLUTION, METERED;TRANSDERMAL
TESTOSTERONE
PADAGIS ISRAEL 30MG/1.5ML ACTUATION A204255 001 Feb 28, 2017RX RLD: N022504
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
TETRACYCLINE HYDROCHLORIDE
AMNEAL PHARMS NY 500MG A210674 002 Sep 18, 2018RX RLD: N050278
THEOPHYLLINE
SOLUTION;ORAL
THEOPHYLLINE
CHARTWELL
MOLECULAR
80MG/15ML A091156 001 Apr 13, 2011RX RLD: A087449
TABLET, EXTENDED RELEASE;ORAL
THEOPHYLLINE
ALEMBIC 450MG A090430 002 Oct 27, 2010RX RLD: A085328
THIOTHIXENE
CAPSULE;ORAL
THIOTHIXENE
NOVITIUM PHARMA 5MG A211642 003 Apr 05, 2019RX RLD: N016584
TIMOLOL MALEATE
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC
TIMOLOL MALEATE
ALEMBIC EQ 0.25% BASE A212942 001 Oct 22, 2020RX RLD: N020330
EQ 0.5% BASE A212942 002 Oct 22, 2020RX RLD: N020330
SOLUTION/DROPS;OPHTHALMIC
TIMOLOL MALEATE
SANDOZ EQ 0.25% BASE A074261 001 Apr 28, 1995RX RLD: N018086
EQ 0.5% BASE A074262 001 Apr 28, 1995RX RLD: N018086
TABLET;ORAL
TIMOLOL MALEATE
MYLAN 20MG A072668 001 Jun 08, 1990RX RLD: N018017
TOBRAMYCIN
SOLUTION/DROPS;OPHTHALMIC
TOBRAMYCIN
SOMERSET THERAPS
LLC
0.3% A207444 001 Jun 28, 2017RX RLD: N050541
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
TRAVOPROST
CHARTWELL RX 0.004% A091340 001 Mar 01, 2013RX RLD: N021257
TRIAMCINOLONE ACETONIDE
OINTMENT;TOPICAL
TRIAMCINOLONE ACETONIDE
ENCUBE 0.05% A212384 001 Nov 29, 2019RX RLD: N011600
SPRAY;TOPICAL
TRIAMCINOLONE ACETONIDE
PADAGIS ISRAEL 0.147MG/GM A205782 001 Apr 13, 2015RX RLD: N012104
TRIMIPRAMINE MALEATE
CAPSULE;ORAL
TRIMIPRAMINE MALEATE
BRECKENRIDGE EQ 50MG BASE A208127 002 Apr 15, 2016RX RLD: N016792
Approved Drug Product List - Orange Book
Page 25 of 25
Reference Listed Drugs by ANDA Reference Standard List
July 2024
URSODIOL
CAPSULE;ORAL
URSODIOL
LGM PHARMA 400MG A205789 002 May 08, 2020RX RLD: N019594
VALSARTAN
SOLUTION;ORAL
VALSARTAN
NOVITIUM PHARMA 20MG/5ML A214102 001 Nov 02, 2021RX RLD: N209139
VARDENAFIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
VARDENAFIL HYDROCHLORIDE
ALEMBIC 10MG A208324 001 Nov 16, 2018RX RLD: N200179
TABLET;ORAL
VARDENAFIL HYDROCHLORIDE
ZYDUS PHARMS EQ 20MG BASE A208960 004 Oct 31, 2018RX RLD: N021400
VARENICLINE TARTRATE
TABLET;ORAL
VARENICLINE TARTRATE
ENDO OPERATIONS EQ 1MG BASE A201785 002 Aug 11, 2021RX RLD: N021928
VERAPAMIL HYDROCHLORIDE
INJECTABLE;INJECTION
VERAPAMIL HYDROCHLORIDE
EUGIA PHARMA 2.5MG/ML A212965 001 Jul 06, 2020RX RLD: N018485
TABLET, EXTENDED RELEASE;ORAL
VERAPAMIL HYDROCHLORIDE
GLENMARK PHARMS
LTD
180MG A090700 002 Aug 03, 2011RX RLD: N019152
TABLET;ORAL
VERAPAMIL HYDROCHLORIDE
HERITAGE PHARMS 120MG A071881 001 Apr 05, 1988RX RLD: N018593
VINBLASTINE SULFATE
INJECTABLE;INJECTION
VINBLASTINE SULFATE
HIKMA 10MG/VIAL A089395 001 Apr 09, 1987RX RLD: N012665
ZILEUTON
TABLET, EXTENDED RELEASE;ORAL
ZILEUTON
RISING 600MG A204929 001 Mar 17, 2017RX RLD: N022052
ZOLEDRONIC ACID
INJECTABLE;INTRAVENOUS
ZOLEDRONIC
GLAND PHARMA LTD EQ 4MG BASE/100ML A205749 001 Jun 29, 2018RX RLD: N021223
ZOLMITRIPTAN
SPRAY;NASAL
ZOLMITRIPTAN
PADAGIS ISRAEL 5MG/SPRAY A212469 002 Sep 30, 2021RX RLD: N021450
TABLET, ORALLY DISINTEGRATING;ORAL
ZOLMITRIPTAN
ZYDUS PHARMS USA
INC
5MG A202890 002 May 15, 2013RX RLD: N021231
TABLET;ORAL
ZOLMITRIPTAN
AJANTA PHARMA LTD 5MG A204041 002 May 20, 2016RX RLD: N020768
