Drugs@FDA: FDA-Approved Drugs

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

December 1, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Carbatrol
NDA #020712
Carbamazepine Capsule, Extended Release; Oral SUPPL-37 Takeda Pharms Usa Labeling Approved
Eovist
NDA #022090
Gadoxetate Disodium Solution; Intravenous SUPPL-19 Bayer Hlthcare Labeling Approved
Methylphenidate Hydrochloride
ANDA #215688
Methylphenidate Hydrochloride Unknown ORIG-1 Ascent Pharms Inc Tentative Approval
Sine-Aid Ib
NDA #019899
Ibuprofen; Pseudoephedrine Hydrochloride Tablet; Oral SUPPL-20 J and J Consumer Inc Labeling Approved

November 30, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Baclofen
ANDA #211555
Baclofen Tablet; Oral SUPPL-6 Eywa Pharma Manufacturing (CMC) Approved
Darzalex Faspro
BLA #761145
Daratumumab;Hyaluronidase-Fihj Injectable; Injection SUPPL-9 Janssen Biotech Efficacy Approved
Depakote
NDA #018723
Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-65 Abbvie Labeling Approved
Depakote
NDA #019680
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-52 Abbvie Labeling Approved
Depakote Er
NDA #021168
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-43 Abbvie Labeling Approved
Estrogel
NDA #021166
Estradiol Gel, Metered; Transdermal SUPPL-17 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel, Metered; Transdermal SUPPL-17 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel; Topical SUPPL-17 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel; Topical SUPPL-17 Ascend Theraps Us Labeling Approved
Ferriprox
NDA #021825
Deferiprone Tablet; Oral SUPPL-10 Chiesi Labeling Approved
Ferriprox
NDA #021825
Deferiprone Tablet; Oral SUPPL-10 Chiesi Labeling Approved
Ferriprox
NDA #208030
Deferiprone Solution; Oral SUPPL-7 Chiesi Labeling Approved
Ferriprox
NDA #208030
Deferiprone Solution; Oral SUPPL-7 Chiesi Labeling Approved
Ferriprox
NDA #212269
Deferiprone Tablet; Oral SUPPL-3 Chiesi Labeling Approved
Ferriprox
NDA #212269
Deferiprone Tablet; Oral SUPPL-3 Chiesi Labeling Approved
Kyprolis
NDA #202714
Carfilzomib Powder; Intravenous SUPPL-33 Onyx Therap Efficacy Approved
Lubiprostone
ANDA #209450
Lubiprostone Capsule; Oral ORIG-1 Amneal Approved
Stavzor
NDA #022152
Valproic Acid Capsule, Delayed Release; Oral SUPPL-9 Bionpharma Inc Labeling Approved

November 29, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aztreonam
ANDA #065439
Aztreonam Injectable; Injection SUPPL-9 Fresenius Kabi Usa Labeling Approved
Aztreonam
ANDA #065439
Aztreonam Injectable; Injection SUPPL-14 Fresenius Kabi Usa Labeling Approved
Chlorpromazine Hydrochloride
ANDA #212630
Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Enaltec Approved
Cytalux
NDA #214907
Pafolacianine Injectable; Injection ORIG-1 On Target Labrotories, Inc. Type 1 - New Molecular Entity Approved
Fenofibric Acid
ANDA #200264
Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-4 Impax Labs Inc Labeling Approved
Fenofibric Acid
ANDA #200750
Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-16 Lupin Ltd Labeling Approved
Lumify
NDA #208144
Brimonidine Tartrate Solution/Drops; Ophthalmic SUPPL-13 Bausch and Lomb Inc Labeling Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral SUPPL-3 Ani Pharms Labeling Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral SUPPL-3 Ani Pharms Labeling Approved
Mycophenolic Acid
ANDA #214630
Mycophenolic Acid Tablet, Delayed Release; Oral ORIG-1 Biocon Pharma Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-2 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-4 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-1 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-2 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-4 Orbion Pharms Labeling Approved
Ribavirin
ANDA #076277
Ribavirin Capsule; Oral SUPPL-13 Teva Labeling Approved
Ribavirin
ANDA #076277
Ribavirin Capsule; Oral SUPPL-13 Teva Labeling Approved
Ursodiol
ANDA #090801
Ursodiol Tablet; Oral SUPPL-5 Glenmark Generics Labeling Approved

November 26, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atropine Sulfate
ANDA #215624
Atropine Sulfate Solution/Drops; Ophthalmic ORIG-1 Apotex Inc Approved
Daptomycin
ANDA #215215
Daptomycin Powder; Intravenous ORIG-1 Hangzhou Zhongmei Approved
Detroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Lannett Co Inc Approved
Everolimus
ANDA #214138
Everolimus Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Intron A
BLA #103132
Interferon Alfa-2b Vial SUPPL-5202 Schering Labeling Approved

November 24, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Buprenorphine Hydrochloride
ANDA #078633
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-24 Hikma Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Lannett Co Inc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Lannett Co Inc Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-4 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-5 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-7 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-4 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-5 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-7 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #203187
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Mylan Labeling Approved
Lansoprazole
ANDA #203187
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-6 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-10 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-2 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-6 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-10 Mylan Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-4 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-5 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-2 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-4 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-5 Orbion Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-19 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-20 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-19 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-20 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #202074
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #202074
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved

December 1, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Carbatrol
NDA #020712
Carbamazepine Capsule, Extended Release; Oral SUPPL-37 Takeda Pharms Usa Labeling Approved
Eovist
NDA #022090
Gadoxetate Disodium Solution; Intravenous SUPPL-19 Bayer Hlthcare Labeling Approved
Methylphenidate Hydrochloride
ANDA #215688
Methylphenidate Hydrochloride Unknown ORIG-1 Ascent Pharms Inc Tentative Approval
Sine-Aid Ib
NDA #019899
Ibuprofen; Pseudoephedrine Hydrochloride Tablet; Oral SUPPL-20 J and J Consumer Inc Labeling Approved

November 30, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Baclofen
ANDA #211555
Baclofen Tablet; Oral SUPPL-6 Eywa Pharma Manufacturing (CMC) Approved
Darzalex Faspro
BLA #761145
Daratumumab;Hyaluronidase-Fihj Injectable; Injection SUPPL-9 Janssen Biotech Efficacy Approved
Depakote
NDA #018723
Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-65 Abbvie Labeling Approved
Depakote
NDA #019680
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-52 Abbvie Labeling Approved
Depakote Er
NDA #021168
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-43 Abbvie Labeling Approved
Estrogel
NDA #021166
Estradiol Gel, Metered; Transdermal SUPPL-17 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel, Metered; Transdermal SUPPL-17 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel; Topical SUPPL-17 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel; Topical SUPPL-17 Ascend Theraps Us Labeling Approved
Ferriprox
NDA #021825
Deferiprone Tablet; Oral SUPPL-10 Chiesi Labeling Approved
Ferriprox
NDA #021825
Deferiprone Tablet; Oral SUPPL-10 Chiesi Labeling Approved
Ferriprox
NDA #208030
Deferiprone Solution; Oral SUPPL-7 Chiesi Labeling Approved
Ferriprox
NDA #208030
Deferiprone Solution; Oral SUPPL-7 Chiesi Labeling Approved
Ferriprox
NDA #212269
Deferiprone Tablet; Oral SUPPL-3 Chiesi Labeling Approved
Ferriprox
NDA #212269
Deferiprone Tablet; Oral SUPPL-3 Chiesi Labeling Approved
Kyprolis
NDA #202714
Carfilzomib Powder; Intravenous SUPPL-33 Onyx Therap Efficacy Approved
Lubiprostone
ANDA #209450
Lubiprostone Capsule; Oral ORIG-1 Amneal Approved
Stavzor
NDA #022152
Valproic Acid Capsule, Delayed Release; Oral SUPPL-9 Bionpharma Inc Labeling Approved

November 29, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aztreonam
ANDA #065439
Aztreonam Injectable; Injection SUPPL-9 Fresenius Kabi Usa Labeling Approved
Aztreonam
ANDA #065439
Aztreonam Injectable; Injection SUPPL-14 Fresenius Kabi Usa Labeling Approved
Chlorpromazine Hydrochloride
ANDA #212630
Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Enaltec Approved
Cytalux
NDA #214907
Pafolacianine Injectable; Injection ORIG-1 On Target Labrotories, Inc. Type 1 - New Molecular Entity Approved
Fenofibric Acid
ANDA #200264
Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-4 Impax Labs Inc Labeling Approved
Fenofibric Acid
ANDA #200750
Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-16 Lupin Ltd Labeling Approved
Lumify
NDA #208144
Brimonidine Tartrate Solution/Drops; Ophthalmic SUPPL-13 Bausch and Lomb Inc Labeling Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral SUPPL-3 Ani Pharms Labeling Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral SUPPL-3 Ani Pharms Labeling Approved
Mycophenolic Acid
ANDA #214630
Mycophenolic Acid Tablet, Delayed Release; Oral ORIG-1 Biocon Pharma Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-2 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-4 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-1 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-2 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202937
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-4 Orbion Pharms Labeling Approved
Ribavirin
ANDA #076277
Ribavirin Capsule; Oral SUPPL-13 Teva Labeling Approved
Ribavirin
ANDA #076277
Ribavirin Capsule; Oral SUPPL-13 Teva Labeling Approved
Ursodiol
ANDA #090801
Ursodiol Tablet; Oral SUPPL-5 Glenmark Generics Labeling Approved

November 26, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atropine Sulfate
ANDA #215624
Atropine Sulfate Solution/Drops; Ophthalmic ORIG-1 Apotex Inc Approved
Daptomycin
ANDA #215215
Daptomycin Powder; Intravenous ORIG-1 Hangzhou Zhongmei Approved
Detroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Lannett Co Inc Approved
Everolimus
ANDA #214138
Everolimus Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Intron A
BLA #103132
Interferon Alfa-2b Vial SUPPL-5202 Schering Labeling Approved

November 24, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Buprenorphine Hydrochloride
ANDA #078633
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-24 Hikma Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Lannett Co Inc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Lannett Co Inc Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-4 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-5 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-7 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-4 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-5 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-7 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #202366
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Zydus Hlthcare Labeling Approved
Lansoprazole
ANDA #203187
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Mylan Labeling Approved
Lansoprazole
ANDA #203187
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-6 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-10 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-2 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-6 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Mylan Labeling Approved
Olanzapine
ANDA #202285
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-10 Mylan Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-4 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-5 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-2 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-3 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-4 Orbion Pharms Labeling Approved
Olanzapine
ANDA #202287
Olanzapine Tablet; Oral SUPPL-5 Orbion Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-19 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-20 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-19 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #077528
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-20 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #202074
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved
Olanzapine and Fluoxetine Hydrochloride
ANDA #202074
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved

November 23, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Allergy and Congestion Relief
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-11 Glaxosmithkline Labeling Approved
Advil Allergy Sinus
NDA #021441
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride Tablet; Oral SUPPL-16 Glaxosmithkline Labeling Approved
Advil Multi-Symptom Cold & Flu
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-11 Glaxosmithkline Labeling Approved
Betaine
ANDA #214864
Betaine For Solution; Oral ORIG-1 Novitium Pharma Approved
Dasatinib
ANDA #203180
Dasatinib Tablet; Oral ORIG-1 Apotex Approved
Everolimus
ANDA #207486
Everolimus Tablet; Oral ORIG-2 Hikma Approved
Inrebic
NDA #212327
Fedratinib Hydrochloride Capsule; Oral SUPPL-4 Impact Labeling Approved
Isosorbide Dinitrate
ANDA #211290
Isosorbide Dinitrate Tablet; Oral ORIG-1 Par Pharm Inc Approved
Livtencity
NDA #215596
Maribavir Tablet; Oral ORIG-1 Takeda Pharms Usa Type 1 - New Molecular Entity Approved
Temozolomide
ANDA #213328
Temozolomide Capsule; Oral ORIG-1 Nivagen Pharms Inc Approved
Tpoxx
NDA #208627
Tecovirimat Capsule; Oral SUPPL-6 Siga Technologies Efficacy Approved

November 22, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-11 Apotex Labeling Approved
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-1 Apotex Labeling Approved
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-9 Apotex Labeling Approved
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-11 Apotex Labeling Approved
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-12 Apotex Labeling Approved
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-9 Apotex Labeling Approved
Abiraterone Acetate
ANDA #208453
Abiraterone Acetate Tablet; Oral SUPPL-12 Apotex Labeling Approved
Azithromycin
ANDA #065150
Azithromycin Tablet; Oral SUPPL-20 Teva Labeling Approved
Azithromycin
ANDA #065209
Azithromycin Tablet; Oral SUPPL-32 Sandoz Labeling Approved
Azithromycin
ANDA #065218
Azithromycin Tablet; Oral SUPPL-24 Pliva Labeling Approved
Azithromycin
ANDA #065302
Azithromycin Tablet; Oral SUPPL-11 Wockhardt Labeling Approved
Azithromycin
ANDA #065360
Azithromycin Tablet; Oral SUPPL-10 Mylan Labeling Approved
Azithromycin
ANDA #065400
Azithromycin Tablet; Oral SUPPL-19 Lupin Ltd Labeling Approved
Azithromycin
ANDA #207566
Azithromycin Tablet; Oral SUPPL-2 Cspc Ouyi Labeling Approved
Azithromycin
ANDA #209043
Azithromycin Tablet; Oral SUPPL-8 Sunshine Labeling Approved
Azithromycin
ANDA #209999
Azithromycin Tablet; Oral SUPPL-2 Bionpharma Inc Labeling Approved
Azithromycin
ANDA #211068
Azithromycin Tablet; Oral SUPPL-2 Yung Shin Pharm Labeling Approved
Azithromycin
ANDA #211793
Azithromycin Tablet; Oral SUPPL-5 Alembic Pharms Ltd Labeling Approved
Cimetidine Hydrochloride
ANDA #074553
Cimetidine Hydrochloride Solution; Oral SUPPL-8 Pharm Assoc Manufacturing (CMC) Approved
Dabigatran Etexilate Mesylate
ANDA #208046
Dabigatran Etexilate Mesylate Capsule; Oral ORIG-1 Alembic Pharms Ltd Tentative Approval
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214347
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral ORIG-1 Accord Hlthcare Approved
Digoxin
ANDA #215307
Digoxin Tablet; Oral ORIG-1 Novitium Pharma Approved
Doxycycline Hyclate
ANDA #208263
Doxycycline Hyclate Capsule; Oral ORIG-1 Nesher Pharms Approved
Formoterol Fumarate
ANDA #215078
Formoterol Fumarate Solution; Inhalation ORIG-1 Alembic Pharms Ltd Approved
Fyarro
NDA #213312
Sirolimus Albumin-Bound Nanoparticles Powder; Intravenous ORIG-1 Aadi Bioscience Inc Type 5 - New Formulation or New Manufacturer Approved
Lyvispah
NDA #215422
Baclofen Granule; Oral ORIG-1 Saol Theraps Res Ltd Type 3 - New Dosage Form Approved
Mercaptopurine
ANDA #040528
Mercaptopurine Tablet; Oral SUPPL-12 Hikma Labeling Approved
Niacin
ANDA #214428
Niacin Tablet, Extended Release; Oral ORIG-1 Beijing Approved
Silodosin
ANDA #209745
Silodosin Capsule; Oral SUPPL-3 Amneal Pharms Co Labeling Approved
Ultomiris
BLA #761108
Ravulizumab-Cwvz Injectable; Injection SUPPL-24 Alexion Pharm REMS Approved
Zithromax
NDA #050670
Azithromycin Capsule; Oral SUPPL-36 Pfizer Labeling Approved
Zithromax
NDA #050693
Azithromycin For Suspension; Oral SUPPL-34 Pfizer Labeling Approved
Zithromax
NDA #050710
Azithromycin For Suspension; Oral SUPPL-51 Pfizer Labeling Approved
Zithromax
NDA #050711
Azithromycin Tablet; Oral SUPPL-50 Pfizer Labeling Approved
Zithromax
NDA #050730
Azithromycin Tablet; Oral SUPPL-43 Pfizer Labeling Approved
Zithromax
NDA #050733
Azithromycin Injectable; Injection SUPPL-50 Pfizer Labeling Approved
Zithromax
NDA #050784
Azithromycin Tablet; Oral SUPPL-37 Pfizer Labeling Approved
Zmax
NDA #050797
Azithromycin For Suspension, Extended Release; Oral SUPPL-26 Pf Prism Cv Labeling Approved
Zmax
NDA #050797
Azithromycin For Suspension, Extended Release; Oral SUPPL-26 Pf Prism Cv Labeling Approved

November 19, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Cold and Sinus
NDA #019771
Ibuprofen; Pseudoephedrine Hydrochloride Tablet; Oral SUPPL-45 Glaxosmithkline Labeling Approved
Advil Cold and Sinus
NDA #021374
Ibuprofen; Pseudoephedrine Hydrochloride Capsule; Oral SUPPL-14 Glaxosmithkline Labeling Approved
Advil Congestion Relief
NDA #022565
Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-9 Glaxosmithkline Labeling Approved
Calan
NDA #018817
Verapamil Hydrochloride Tablet; Oral SUPPL-35 Pfizer Labeling Approved
Caldolor
NDA #022348
Ibuprofen Solution; Intravenous SUPPL-21 Cumberland Pharms Efficacy Approved
Decitabine
ANDA #214486
Decitabine Injectable; Intravenous ORIG-1 Zydus Pharms Approved
Deferasirox
ANDA #214180
Deferasirox Granule; Oral ORIG-1 Teva Pharms Usa Approved
Injectafer
NDA #203565
Ferric Carboxymaltose Solution; Intravenous SUPPL-16 Am Regent Efficacy Approved
Isoproterenol Hydrochloride
ANDA #212189
Isoproterenol Hydrochloride Injectable; Injection ORIG-1 Avet Lifesciences Approved
Kanuma
BLA #125561
Sebelipase Alfa Injectable; Injection SUPPL-13 Alexion Pharm Efficacy Approved
Nebivolol Hydrochloride
ANDA #203828
Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Indchemie Health Labeling Approved
Nebivolol Hydrochloride
ANDA #203828
Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Indchemie Health Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-11 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-18 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-25 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-26 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-11 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-18 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-25 Macleods Pharms Ltd Labeling Approved
Olanzapine
ANDA #202862
Olanzapine Tablet; Oral SUPPL-26 Macleods Pharms Ltd Labeling Approved
Suboxone
NDA #020733
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-29 Indivior Inc REMS Approved
Suboxone
NDA #022410
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-44 Indivior Inc REMS Approved
Subutex
NDA #020732
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-25 Indivior Inc REMS Approved
Voxzogo
NDA #214938
Vosoritide Powder; Subcutaneous ORIG-1 Biomarin Pharm Type 1 - New Molecular Entity Approved

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