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 3, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Children's Allegra Allergy
NDA #021909
Fexofenadine Hydrochloride Tablet, Orally Disintegrating; Oral SUPPL-15 Sanofi Aventis Us Labeling Approved
Children's Allegra Hives
NDA #021909
Fexofenadine Hydrochloride Tablet, Orally Disintegrating; Oral SUPPL-15 Sanofi Aventis Us Labeling Approved
Lumason
NDA #203684
Sulfur Hexafluoride Lipid-Type A Microspheres For Suspension; Intravenous SUPPL-7 Bracco Labeling Approved
Pomalyst
NDA #204026
Pomalidomide Capsule; Oral SUPPL-28 Celgene Labeling Approved

December 2, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Austedo
NDA #208082
Deutetrabenazine Tablet; Oral SUPPL-7 Teva Branded Pharm Labeling Approved
Bydureon Bcise
NDA #209210
Exenatide Suspension, Extended Release; Subcutaneous SUPPL-14 Astrazeneca Ab Labeling Approved
Ferrlecit
NDA #020955
Sodium Ferric Gluconate Complex Injectable; Injection SUPPL-19 Sanofi Aventis Us Labeling Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-24 Gilead Sciences Inc Labeling Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-24 Gilead Sciences Inc Labeling Approved
Zilretta
NDA #208845
Triamcinolone Acetonide For Suspension, Extended Release; Intra-Articular SUPPL-11 Flexion Theraps Inc Labeling Approved

December 1, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Daunorubicin Hydrochloride
ANDA #208759
Daunorubicin Hydrochloride Injectable; Injection SUPPL-2 Hisun Pharm Hangzhou Manufacturing (CMC) Approved
Daunorubicin Hydrochloride
ANDA #208759
Daunorubicin Hydrochloride Injectable; Injection SUPPL-2 Hisun Pharm Hangzhou Manufacturing (CMC) Approved
Droxidopa
ANDA #213911
Droxidopa Unknown ORIG-1 Alkem Labs Ltd Tentative Approval
Finacea
NDA #207071
Azelaic Acid Aerosol, Foam; Topical SUPPL-2 Leo Pharma As Labeling Approved
Finacea
NDA #207071
Azelaic Acid Aerosol, Foam; Topical SUPPL-4 Leo Pharma As Labeling Approved
Gallium Ga 68 Psma-11
NDA #212642
Psma-11 Ga 68 Injectable; Injection ORIG-1 Univ California Los Angeles Type 1 - New Molecular Entity Approved
Gallium Ga 68 Psma-11
NDA #212643
Psma-11 Ga 68 Injectable; Injection ORIG-1 Univ California Los Angeles Type 1 - New Molecular Entity Approved
Gavreto
NDA #214701
Pralsetinib Capsule; Oral ORIG-1 Blueprint Medicines Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved
Hetlioz
NDA #205677
Tasimelteon Capsule; Oral SUPPL-7 Vanda Pharms Inc Efficacy Approved
Hetlioz
NDA #214517
Tasimelteon Capsule; Oral ORIG-1 Vanda Pharmaceuticals Inc Type 3 - New Dosage Form Approved
Hetlioz Lq
NDA #214517
Tasimelteon Suspension; Oral ORIG-1 Vanda Pharmaceuticals Inc Type 3 - New Dosage Form Approved
Lidocaine
ANDA #203265
Lidocaine Patch; Topical ORIG-1 Noven Pharms Inc Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-64 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-64 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-64 Lannett Co Inc Labeling Approved
Ropinirole Hydrochloride
ANDA #079050
Ropinirole Hydrochloride Tablet; Oral SUPPL-5 Celltrion Labeling Approved
Stelara
BLA #125261
Ustekinumab Injectable; Injection SUPPL-154 Centocor Ortho Biotech Inc Labeling Approved
Stelara
BLA #125261
Ustekinumab Injectable; Injection SUPPL-154 Centocor Ortho Biotech Inc Labeling Approved
Stelara
BLA #761044
Ustekinumab Injectable; Injection SUPPL-6 Janssen Biotech Labeling Approved
Stelara
BLA #761044
Ustekinumab Injectable; Injection SUPPL-6 Janssen Biotech Labeling Approved

November 30, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-13 Bayer Hlthcare REMS Approved
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-13 Bayer Hlthcare REMS Approved
Amitiza
NDA #021908
Lubiprostone Capsule; Oral SUPPL-18 Sucampo Pharma Llc Labeling Approved
Athentia Next
ANDA #206867
Levonorgestrel Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Athentia Next
ANDA #206867
Levonorgestrel Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Axitinib
ANDA #213235
Axitinib Unknown ORIG-1 Glenmark Pharms Ltd Tentative Approval
Bupropion Hydrochloride
ANDA #200216
Bupropion Hydrochloride Tablet, Extended Release; Oral ORIG-1 Sun Pharm Approved
Byfavo
NDA #212295
Remimazolam Besylate Powder; Intravenous SUPPL-1 Acacia Labeling Approved
Byfavo
NDA #212295
Remimazolam Besylate Powder; Intravenous SUPPL-1 Acacia Labeling Approved
Cenestin
NDA #020992
Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-38 Aspen Labeling Approved
Cenestin
NDA #020992
Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-39 Aspen Labeling Approved
Clofarabine
ANDA #209775
Clofarabine Solution; Intravenous SUPPL-1 Msn Labeling Approved
Dofetilde
ANDA #210740
Dofetilide Capsule; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Enjuvia
NDA #021443
Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-11 Aspen Labeling Approved
Enjuvia
NDA #021443
Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-12 Aspen Labeling Approved
Irbesartan
ANDA #203534
Irbesartan Tablet; Oral SUPPL-6 Jubilant Generics Labeling Approved
Penicillamine
ANDA #212933
Penicillamine Tablet; Oral ORIG-1 Lupin Ltd Approved
Ranolazine
ANDA #209953
Ranolazine Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
Riociguat
ANDA #211135
Riociguat Unknown ORIG-1 Msn Laboratories Private Ltd Tentative Approval
Sodium Chloride 0.45% In Plastic Container
ANDA #208122
Sodium Chloride Injectable; Injection SUPPL-6 Fresenius Kabi Usa Manufacturing (CMC) Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-30 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-31 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-30 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-31 Auxilium Pharms Llc Labeling Approved
Thyquidity
NDA #214047
Levothyroxine Sodium Solution; Oral ORIG-1 Reguliance Llc Type 5 - New Formulation or New Manufacturer Approved
Xolair
BLA #103976
Omalizumab Vial SUPPL-5235 Genentech Efficacy Approved

November 27, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aciphex
NDA #020973
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-41 Eisai Inc Labeling Approved
Aciphex Sprinkle
NDA #204736
Rabeprazole Sodium Capsule, Delayed Release; Oral SUPPL-12 Aytu Labeling Approved
Brinzolamide
ANDA #209406
Brinzolamide Suspension/Drops; Ophthalmic ORIG-1 Watson Labs Inc Approved
Chlorthalidone
ANDA #214129
Chlorthalidone Tablet; Oral ORIG-1 Ajanta Pharma Ltd Approved
Dexilant
NDA #022287
Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved
Dexilant
NDA #022287
Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved
Esomeprazole Strontium
NDA #202342
Esomeprazole Strontium Capsule, Delayed Release; Oral SUPPL-6 Belcher Labeling Approved
Finacea
NDA #021470
Azelaic Acid Gel; Topical SUPPL-15 Leo Pharma As Labeling Approved
Finacea
NDA #021470
Azelaic Acid Gel; Topical SUPPL-16 Leo Pharma As Labeling Approved
Fluconazole In Sodium Chloride 0.9%
ANDA #076087
Fluconazole Injectable; Injection SUPPL-15 West-Ward Pharms Int Labeling Approved
Fluconazole In Sodium Chloride 0.9%
ANDA #076087
Fluconazole Injectable; Injection SUPPL-16 West-Ward Pharms Int Labeling Approved
Levetiracetam
ANDA #205130
Levetiracetam Tablet, Extended Release; Oral ORIG-1 Sciegen Pharms Inc Approved
Methenamine Hippurate
ANDA #210068
Methenamine Hippurate Tablet; Oral ORIG-1 Riconpharma Llc Approved
Nexium
NDA #021153
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-57 Astrazeneca Pharms Labeling Approved
Nexium
NDA #021957
Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-24 Astrazeneca Pharms Labeling Approved
Nexium
NDA #022101
Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-21 Astrazeneca Pharms Labeling Approved
Nexium Iv
NDA #021689
Esomeprazole Sodium Injectable; Intravenous SUPPL-35 Astrazeneca Pharms Labeling Approved
Nitazoxanide
ANDA #213820
Nitazoxanide Tablet; Oral ORIG-1 Rising Approved
Omeprazole
ANDA #075347
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-27 Actavis Labs Fl Inc Labeling Approved
Omeprazole
ANDA #075347
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-27 Actavis Labs Fl Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-62 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-62 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075576
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Omeprazole
ANDA #075576
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Omeprazole
ANDA #075757
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-52 Sandoz Labeling Approved
Omeprazole
ANDA #075757
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-52 Sandoz Labeling Approved
Omeprazole
ANDA #075785
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-11 Impax Labs Labeling Approved
Omeprazole
ANDA #075876
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-42 Mylan Labeling Approved
Omeprazole
ANDA #075876
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-42 Mylan Labeling Approved
Omeprazole
ANDA #076048
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-23 Apotex Labeling Approved
Omeprazole
ANDA #076048
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-23 Apotex Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-32 Sandoz Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-33 Sandoz Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-32 Sandoz Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-33 Sandoz Labeling Approved
Omeprazole
ANDA #091352
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-18 Zydus Pharms Usa Inc Labeling Approved
Omeprazole
ANDA #091352
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-18 Zydus Pharms Usa Inc Labeling Approved
Omeprazole
ANDA #091352
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-20 Zydus Pharms Usa Inc Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-19 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-19 Glenmark Generics Labeling Approved
Omeprazole
ANDA #203270
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Aurobindo Pharma Ltd Labeling Approved
Omeprazole
ANDA #204012
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-1 Hetero Labs Ltd Iii Labeling Approved
Omeprazole
ANDA #205070
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-2 Mylan Labeling Approved
Omeprazole
ANDA #205070
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-2 Mylan Labeling Approved
Omeprazole and Clarithromycin and Amoxicillin
NDA #050824
Amoxicillin; Clarithromycin; Omeprazole Capsule, Tablet, Capsule, Delayed Release; Oral SUPPL-9 Cumberland Pharms Labeling Approved
Pantoprazole Sodium
NDA #209463
Pantoprazole Sodium Powder; Iv (Infusion) SUPPL-11 Hikma Labeling Approved
Prevacid
NDA #020406
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #020406
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #021428
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #021428
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved
Prilosec
NDA #022056
Omeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-23 Covis Pharma Bv Labeling Approved
Protonix
NDA #020987
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-56 Wyeth Pharms Labeling Approved
Protonix
NDA #022020
Pantoprazole Sodium For Suspension, Delayed Release; Oral SUPPL-18 Wyeth Pharms Labeling Approved
Protonix Iv
NDA #020988
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-62 Wyeth Pharms Labeling Approved
Talicia
NDA #213004
Amoxicillin; Omeprazole Magnesium; Rifabutin Capsule, Delayed Release; Oral SUPPL-2 Redhill Labeling Approved
Teflaro
NDA #200327
Ceftaroline Fosamil Powder; Intravenous SUPPL-25 Allergan Labeling Approved
Vimovo
NDA #022511
Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-25 Horizon Labeling Approved
Yosprala
NDA #205103
Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved
Yosprala
NDA #205103
Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved
Zegerid
NDA #021636
Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-22 Salix Labeling Approved
Zegerid
NDA #021849
Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-16 Salix Labeling Approved

November 25, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atenolol and Chlorthalidone
ANDA #213302
Atenolol; Chlorthalidone Tablet; Oral ORIG-1 Unichem Approved
Azelastine Hydrochloride and Fluticasone Propionate
ANDA #207712
Azelastine Hydrochloride; Fluticasone Propionate Spray, Metered; Nasal SUPPL-4 Apotex Manufacturing (CMC) Approved
Danyelza
BLA #761171
Naxitamab-Gqgk Solution; Intravenous ORIG-1 Y-Mabs Therapeutics Inc Type 1 - New Molecular Entity Approved
Gefitinib
ANDA #209792
Gefitinib Unknown ORIG-1 Synthon Pharms Tentative Approval
Guanfacine Hydrochloride
ANDA #213428
Guanfacine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Yichang Humanwell Approved
Imcivree
NDA #213793
Setmelanotide Solution; Subcutaneous ORIG-1 Rhythm Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Jynarque
NDA #204441
Tolvaptan Tablet; Oral SUPPL-9 Otsuka Pharm Co Ltd REMS Approved
Metoprolol Succinate
ANDA #211143
Metoprolol Succinate Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
Micafungin Sodium
NDA #212125
Micafungin Sodium Unknown ORIG-1 Teva Pharms Usa Type 5 - New Formulation or New Manufacturer Tentative Approval
Sildenafil Citrate
ANDA #202506
Sildenafil Citrate Tablet; Oral ORIG-1 Watson Labs Inc Approved
Tavaborole
ANDA #212256
Tavaborole Solution; Topical ORIG-1 Amneal Approved
Testosterone
ANDA #209181
Testosterone Solution, Metered; Transdermal ORIG-1 Apotex Approved
Vincristine Sulfate Pfs
ANDA #075493
Vincristine Sulfate Injectable; Injection SUPPL-39 Teva Pharms Usa Labeling Approved
Vincristine Sulfate Pfs
ANDA #075493
Vincristine Sulfate Injectable; Injection SUPPL-41 Teva Pharms Usa Labeling Approved
Vincristine Sulfate Pfs
ANDA #075493
Vincristine Sulfate Injectable; Injection SUPPL-41 Teva Pharms Usa Labeling Approved

November 24, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bimatoprost
ANDA #203991
Bimatoprost Solution/Drops; Ophthalmic SUPPL-9 Lupin Ltd Manufacturing (CMC) Approved
Clariscan
ANDA #210016
Gadoterate Meglumine Solution; Intravenous SUPPL-3 Ge Healthcare Labeling Approved
Docetaxel
NDA #022234
Docetaxel Injectable; Injection SUPPL-18 Hospira Inc Labeling Approved
Eletriptan Hydrobromide
ANDA #206409
Eletriptan Hydrobromide Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Eletriptan Hydrobromide
ANDA #206409
Eletriptan Hydrobromide Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Eletriptan Hydrobromide
ANDA #210708
Eletriptan Hydrobromide Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Ephedrine Sulfate
ANDA #209784
Ephedrine Sulfate Solution; Intravenous SUPPL-2 Sandoz Inc Labeling Approved
Etodolac
ANDA #212263
Etodolac Tablet, Extended Release; Oral ORIG-1 Bayshore Pharms Llc Approved
Idhifa
NDA #209606
Enasidenib Mesylate Tablet; Oral SUPPL-4 Celgene Corp Efficacy Approved
Montelukast Sodium
ANDA #203366
Montelukast Sodium Tablet; Oral SUPPL-20 Macleods Pharms Ltd Labeling Approved
Montelukast Sodium
ANDA #203366
Montelukast Sodium Tablet; Oral SUPPL-20 Macleods Pharms Ltd Labeling Approved
Phenylephrine Hydrochloride
ANDA #210333
Phenylephrine Hydrochloride Solution; Intravenous SUPPL-2 Meitheal Labeling Approved
Phenylephrine Hydrochloride
ANDA #210333
Phenylephrine Hydrochloride Solution; Intravenous SUPPL-2 Meitheal Labeling Approved
Rydapt
NDA #207997
Midostaurin Capsule; Oral SUPPL-6 Novartis Efficacy Approved
Scopolamine
ANDA #212342
Scopolamine Film, Extended Release; Transdermal ORIG-1 Riconpharma Llc Approved
Solifenacin Succinate
ANDA #209239
Solifenacin Succinate Tablet; Oral SUPPL-1 Glenmark Pharms Inc Labeling Approved
Solifenacin Succinate
ANDA #209839
Solifenacin Succinate Tablet; Oral SUPPL-4 Cipla Labeling Approved
Solifenacin Succinate
ANDA #209839
Solifenacin Succinate Tablet; Oral SUPPL-4 Cipla Labeling Approved
Succinylcholine Chloride
ANDA #213229
Succinylcholine Chloride Injectable; Injection SUPPL-1 Hikma Labeling Approved
Succinylcholine Chloride
ANDA #214879
Succinylcholine Chloride Injectable; Injection ORIG-1 Micro Labs Approved
Testosterone
ANDA #213922
Testosterone Unknown ORIG-1 Aleor Dermaceuticals Tentative Approval
Valcyte
NDA #021304
Valganciclovir Hydrochloride Tablet; Oral SUPPL-16 Hoffmann La Roche Labeling Approved
Valcyte
NDA #022257
Valganciclovir Hydrochloride For Solution; Oral SUPPL-11 Hoffmann La Roche Labeling Approved
Ziagen
NDA #020977
Abacavir Sulfate Tablet; Oral SUPPL-35 Viiv Hlthcare Labeling Approved
Ziagen
NDA #020978
Abacavir Sulfate Solution; Oral SUPPL-38 Viiv Hlthcare Labeling Approved
Zolpidem Tartrate
ANDA #077359
Zolpidem Tartrate Tablet; Oral SUPPL-10 Sun Pharm Inds Inc Labeling Approved
Zolpidem Tartrate
ANDA #077359
Zolpidem Tartrate Tablet; Oral SUPPL-9 Sun Pharm Inds Inc Labeling Approved
Zolpidem Tartrate
ANDA #077359
Zolpidem Tartrate Tablet; Oral SUPPL-10 Sun Pharm Inds Inc Labeling Approved

December 3, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Children's Allegra Allergy
NDA #021909
Fexofenadine Hydrochloride Tablet, Orally Disintegrating; Oral SUPPL-15 Sanofi Aventis Us Labeling Approved
Children's Allegra Hives
NDA #021909
Fexofenadine Hydrochloride Tablet, Orally Disintegrating; Oral SUPPL-15 Sanofi Aventis Us Labeling Approved
Lumason
NDA #203684
Sulfur Hexafluoride Lipid-Type A Microspheres For Suspension; Intravenous SUPPL-7 Bracco Labeling Approved
Pomalyst
NDA #204026
Pomalidomide Capsule; Oral SUPPL-28 Celgene Labeling Approved

December 2, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Austedo
NDA #208082
Deutetrabenazine Tablet; Oral SUPPL-7 Teva Branded Pharm Labeling Approved
Bydureon Bcise
NDA #209210
Exenatide Suspension, Extended Release; Subcutaneous SUPPL-14 Astrazeneca Ab Labeling Approved
Ferrlecit
NDA #020955
Sodium Ferric Gluconate Complex Injectable; Injection SUPPL-19 Sanofi Aventis Us Labeling Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-24 Gilead Sciences Inc Labeling Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-24 Gilead Sciences Inc Labeling Approved
Zilretta
NDA #208845
Triamcinolone Acetonide For Suspension, Extended Release; Intra-Articular SUPPL-11 Flexion Theraps Inc Labeling Approved

December 1, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Daunorubicin Hydrochloride
ANDA #208759
Daunorubicin Hydrochloride Injectable; Injection SUPPL-2 Hisun Pharm Hangzhou Manufacturing (CMC) Approved
Daunorubicin Hydrochloride
ANDA #208759
Daunorubicin Hydrochloride Injectable; Injection SUPPL-2 Hisun Pharm Hangzhou Manufacturing (CMC) Approved
Droxidopa
ANDA #213911
Droxidopa Unknown ORIG-1 Alkem Labs Ltd Tentative Approval
Finacea
NDA #207071
Azelaic Acid Aerosol, Foam; Topical SUPPL-2 Leo Pharma As Labeling Approved
Finacea
NDA #207071
Azelaic Acid Aerosol, Foam; Topical SUPPL-4 Leo Pharma As Labeling Approved
Gallium Ga 68 Psma-11
NDA #212642
Psma-11 Ga 68 Injectable; Injection ORIG-1 Univ California Los Angeles Type 1 - New Molecular Entity Approved
Gallium Ga 68 Psma-11
NDA #212643
Psma-11 Ga 68 Injectable; Injection ORIG-1 Univ California Los Angeles Type 1 - New Molecular Entity Approved
Gavreto
NDA #214701
Pralsetinib Capsule; Oral ORIG-1 Blueprint Medicines Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved
Hetlioz
NDA #205677
Tasimelteon Capsule; Oral SUPPL-7 Vanda Pharms Inc Efficacy Approved
Hetlioz
NDA #214517
Tasimelteon Capsule; Oral ORIG-1 Vanda Pharmaceuticals Inc Type 3 - New Dosage Form Approved
Hetlioz Lq
NDA #214517
Tasimelteon Suspension; Oral ORIG-1 Vanda Pharmaceuticals Inc Type 3 - New Dosage Form Approved
Lidocaine
ANDA #203265
Lidocaine Patch; Topical ORIG-1 Noven Pharms Inc Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-64 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-64 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-64 Lannett Co Inc Labeling Approved
Ropinirole Hydrochloride
ANDA #079050
Ropinirole Hydrochloride Tablet; Oral SUPPL-5 Celltrion Labeling Approved
Stelara
BLA #125261
Ustekinumab Injectable; Injection SUPPL-154 Centocor Ortho Biotech Inc Labeling Approved
Stelara
BLA #125261
Ustekinumab Injectable; Injection SUPPL-154 Centocor Ortho Biotech Inc Labeling Approved
Stelara
BLA #761044
Ustekinumab Injectable; Injection SUPPL-6 Janssen Biotech Labeling Approved
Stelara
BLA #761044
Ustekinumab Injectable; Injection SUPPL-6 Janssen Biotech Labeling Approved

November 30, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-13 Bayer Hlthcare REMS Approved
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-13 Bayer Hlthcare REMS Approved
Amitiza
NDA #021908
Lubiprostone Capsule; Oral SUPPL-18 Sucampo Pharma Llc Labeling Approved
Athentia Next
ANDA #206867
Levonorgestrel Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Athentia Next
ANDA #206867
Levonorgestrel Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Axitinib
ANDA #213235
Axitinib Unknown ORIG-1 Glenmark Pharms Ltd Tentative Approval
Bupropion Hydrochloride
ANDA #200216
Bupropion Hydrochloride Tablet, Extended Release; Oral ORIG-1 Sun Pharm Approved
Byfavo
NDA #212295
Remimazolam Besylate Powder; Intravenous SUPPL-1 Acacia Labeling Approved
Byfavo
NDA #212295
Remimazolam Besylate Powder; Intravenous SUPPL-1 Acacia Labeling Approved
Cenestin
NDA #020992
Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-38 Aspen Labeling Approved
Cenestin
NDA #020992
Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-39 Aspen Labeling Approved
Clofarabine
ANDA #209775
Clofarabine Solution; Intravenous SUPPL-1 Msn Labeling Approved
Dofetilde
ANDA #210740
Dofetilide Capsule; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Enjuvia
NDA #021443
Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-11 Aspen Labeling Approved
Enjuvia
NDA #021443
Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-12 Aspen Labeling Approved
Irbesartan
ANDA #203534
Irbesartan Tablet; Oral SUPPL-6 Jubilant Generics Labeling Approved
Penicillamine
ANDA #212933
Penicillamine Tablet; Oral ORIG-1 Lupin Ltd Approved
Ranolazine
ANDA #209953
Ranolazine Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
Riociguat
ANDA #211135
Riociguat Unknown ORIG-1 Msn Laboratories Private Ltd Tentative Approval
Sodium Chloride 0.45% In Plastic Container
ANDA #208122
Sodium Chloride Injectable; Injection SUPPL-6 Fresenius Kabi Usa Manufacturing (CMC) Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-30 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-31 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-30 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-31 Auxilium Pharms Llc Labeling Approved
Thyquidity
NDA #214047
Levothyroxine Sodium Solution; Oral ORIG-1 Reguliance Llc Type 5 - New Formulation or New Manufacturer Approved
Xolair
BLA #103976
Omalizumab Vial SUPPL-5235 Genentech Efficacy Approved

November 27, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aciphex
NDA #020973
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-41 Eisai Inc Labeling Approved
Aciphex Sprinkle
NDA #204736
Rabeprazole Sodium Capsule, Delayed Release; Oral SUPPL-12 Aytu Labeling Approved
Brinzolamide
ANDA #209406
Brinzolamide Suspension/Drops; Ophthalmic ORIG-1 Watson Labs Inc Approved
Chlorthalidone
ANDA #214129
Chlorthalidone Tablet; Oral ORIG-1 Ajanta Pharma Ltd Approved
Dexilant
NDA #022287
Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved
Dexilant
NDA #022287
Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved
Esomeprazole Strontium
NDA #202342
Esomeprazole Strontium Capsule, Delayed Release; Oral SUPPL-6 Belcher Labeling Approved
Finacea
NDA #021470
Azelaic Acid Gel; Topical SUPPL-15 Leo Pharma As Labeling Approved
Finacea
NDA #021470
Azelaic Acid Gel; Topical SUPPL-16 Leo Pharma As Labeling Approved
Fluconazole In Sodium Chloride 0.9%
ANDA #076087
Fluconazole Injectable; Injection SUPPL-15 West-Ward Pharms Int Labeling Approved
Fluconazole In Sodium Chloride 0.9%
ANDA #076087
Fluconazole Injectable; Injection SUPPL-16 West-Ward Pharms Int Labeling Approved
Levetiracetam
ANDA #205130
Levetiracetam Tablet, Extended Release; Oral ORIG-1 Sciegen Pharms Inc Approved
Methenamine Hippurate
ANDA #210068
Methenamine Hippurate Tablet; Oral ORIG-1 Riconpharma Llc Approved
Nexium
NDA #021153
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-57 Astrazeneca Pharms Labeling Approved
Nexium
NDA #021957
Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-24 Astrazeneca Pharms Labeling Approved
Nexium
NDA #022101
Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-21 Astrazeneca Pharms Labeling Approved
Nexium Iv
NDA #021689
Esomeprazole Sodium Injectable; Intravenous SUPPL-35 Astrazeneca Pharms Labeling Approved
Nitazoxanide
ANDA #213820
Nitazoxanide Tablet; Oral ORIG-1 Rising Approved
Omeprazole
ANDA #075347
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-27 Actavis Labs Fl Inc Labeling Approved
Omeprazole
ANDA #075347
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-27 Actavis Labs Fl Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-62 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075410
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-62 Lannett Co Inc Labeling Approved
Omeprazole
ANDA #075576
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Omeprazole
ANDA #075576
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Omeprazole
ANDA #075757
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-52 Sandoz Labeling Approved
Omeprazole
ANDA #075757
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-52 Sandoz Labeling Approved
Omeprazole
ANDA #075785
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-11 Impax Labs Labeling Approved
Omeprazole
ANDA #075876
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-42 Mylan Labeling Approved
Omeprazole
ANDA #075876
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-42 Mylan Labeling Approved
Omeprazole
ANDA #076048
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-23 Apotex Labeling Approved
Omeprazole
ANDA #076048
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-23 Apotex Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-32 Sandoz Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-33 Sandoz Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-32 Sandoz Labeling Approved
Omeprazole
ANDA #076515
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-33 Sandoz Labeling Approved
Omeprazole
ANDA #091352
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-18 Zydus Pharms Usa Inc Labeling Approved
Omeprazole
ANDA #091352
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-18 Zydus Pharms Usa Inc Labeling Approved
Omeprazole
ANDA #091352
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-20 Zydus Pharms Usa Inc Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-19 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Glenmark Generics Labeling Approved
Omeprazole
ANDA #091672
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-19 Glenmark Generics Labeling Approved
Omeprazole
ANDA #203270
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Aurobindo Pharma Ltd Labeling Approved
Omeprazole
ANDA #204012
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-1 Hetero Labs Ltd Iii Labeling Approved
Omeprazole
ANDA #205070
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-2 Mylan Labeling Approved
Omeprazole
ANDA #205070
Omeprazole Capsule, Delayed Rel Pellets; Oral SUPPL-2 Mylan Labeling Approved
Omeprazole and Clarithromycin and Amoxicillin
NDA #050824
Amoxicillin; Clarithromycin; Omeprazole Capsule, Tablet, Capsule, Delayed Release; Oral SUPPL-9 Cumberland Pharms Labeling Approved
Pantoprazole Sodium
NDA #209463
Pantoprazole Sodium Powder; Iv (Infusion) SUPPL-11 Hikma Labeling Approved
Prevacid
NDA #020406
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #020406
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #021428
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #021428
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved
Prilosec
NDA #022056
Omeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-23 Covis Pharma Bv Labeling Approved
Protonix
NDA #020987
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-56 Wyeth Pharms Labeling Approved
Protonix
NDA #022020
Pantoprazole Sodium For Suspension, Delayed Release; Oral SUPPL-18 Wyeth Pharms Labeling Approved
Protonix Iv
NDA #020988
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-62 Wyeth Pharms Labeling Approved
Talicia
NDA #213004
Amoxicillin; Omeprazole Magnesium; Rifabutin Capsule, Delayed Release; Oral SUPPL-2 Redhill Labeling Approved
Teflaro
NDA #200327
Ceftaroline Fosamil Powder; Intravenous SUPPL-25 Allergan Labeling Approved
Vimovo
NDA #022511
Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-25 Horizon Labeling Approved
Yosprala
NDA #205103
Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved
Yosprala
NDA #205103
Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved
Zegerid
NDA #021636
Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-22 Salix Labeling Approved
Zegerid
NDA #021849
Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-16 Salix Labeling Approved

November 25, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atenolol and Chlorthalidone
ANDA #213302
Atenolol; Chlorthalidone Tablet; Oral ORIG-1 Unichem Approved
Azelastine Hydrochloride and Fluticasone Propionate
ANDA #207712
Azelastine Hydrochloride; Fluticasone Propionate Spray, Metered; Nasal SUPPL-4 Apotex Manufacturing (CMC) Approved
Danyelza
BLA #761171
Naxitamab-Gqgk Solution; Intravenous ORIG-1 Y-Mabs Therapeutics Inc Type 1 - New Molecular Entity Approved
Gefitinib
ANDA #209792
Gefitinib Unknown ORIG-1 Synthon Pharms Tentative Approval
Guanfacine Hydrochloride
ANDA #213428
Guanfacine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Yichang Humanwell Approved
Imcivree
NDA #213793
Setmelanotide Solution; Subcutaneous ORIG-1 Rhythm Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Jynarque
NDA #204441
Tolvaptan Tablet; Oral SUPPL-9 Otsuka Pharm Co Ltd REMS Approved
Metoprolol Succinate
ANDA #211143
Metoprolol Succinate Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
Micafungin Sodium
NDA #212125
Micafungin Sodium Unknown ORIG-1 Teva Pharms Usa Type 5 - New Formulation or New Manufacturer Tentative Approval
Sildenafil Citrate
ANDA #202506
Sildenafil Citrate Tablet; Oral ORIG-1 Watson Labs Inc Approved
Tavaborole
ANDA #212256
Tavaborole Solution; Topical ORIG-1 Amneal Approved
Testosterone
ANDA #209181
Testosterone Solution, Metered; Transdermal ORIG-1 Apotex Approved
Vincristine Sulfate Pfs
ANDA #075493
Vincristine Sulfate Injectable; Injection SUPPL-39 Teva Pharms Usa Labeling Approved
Vincristine Sulfate Pfs
ANDA #075493
Vincristine Sulfate Injectable; Injection SUPPL-41 Teva Pharms Usa Labeling Approved
Vincristine Sulfate Pfs
ANDA #075493
Vincristine Sulfate Injectable; Injection SUPPL-41 Teva Pharms Usa Labeling Approved

November 24, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bimatoprost
ANDA #203991
Bimatoprost Solution/Drops; Ophthalmic SUPPL-9 Lupin Ltd Manufacturing (CMC) Approved
Clariscan
ANDA #210016
Gadoterate Meglumine Solution; Intravenous SUPPL-3 Ge Healthcare Labeling Approved
Docetaxel
NDA #022234
Docetaxel Injectable; Injection SUPPL-18 Hospira Inc Labeling Approved
Eletriptan Hydrobromide
ANDA #206409
Eletriptan Hydrobromide Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Eletriptan Hydrobromide
ANDA #206409
Eletriptan Hydrobromide Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Eletriptan Hydrobromide
ANDA #210708
Eletriptan Hydrobromide Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Ephedrine Sulfate
ANDA #209784
Ephedrine Sulfate Solution; Intravenous SUPPL-2 Sandoz Inc Labeling Approved
Etodolac
ANDA #212263
Etodolac Tablet, Extended Release; Oral ORIG-1 Bayshore Pharms Llc Approved
Idhifa
NDA #209606
Enasidenib Mesylate Tablet; Oral SUPPL-4 Celgene Corp Efficacy Approved
Montelukast Sodium
ANDA #203366
Montelukast Sodium Tablet; Oral SUPPL-20 Macleods Pharms Ltd Labeling Approved
Montelukast Sodium
ANDA #203366
Montelukast Sodium Tablet; Oral SUPPL-20 Macleods Pharms Ltd Labeling Approved
Phenylephrine Hydrochloride
ANDA #210333
Phenylephrine Hydrochloride Solution; Intravenous SUPPL-2 Meitheal Labeling Approved
Phenylephrine Hydrochloride
ANDA #210333
Phenylephrine Hydrochloride Solution; Intravenous SUPPL-2 Meitheal Labeling Approved
Rydapt
NDA #207997
Midostaurin Capsule; Oral SUPPL-6 Novartis Efficacy Approved
Scopolamine
ANDA #212342
Scopolamine Film, Extended Release; Transdermal ORIG-1 Riconpharma Llc Approved
Solifenacin Succinate
ANDA #209239
Solifenacin Succinate Tablet; Oral SUPPL-1 Glenmark Pharms Inc Labeling Approved
Solifenacin Succinate
ANDA #209839
Solifenacin Succinate Tablet; Oral SUPPL-4 Cipla Labeling Approved
Solifenacin Succinate
ANDA #209839
Solifenacin Succinate Tablet; Oral SUPPL-4 Cipla Labeling Approved
Succinylcholine Chloride
ANDA #213229
Succinylcholine Chloride Injectable; Injection SUPPL-1 Hikma Labeling Approved
Succinylcholine Chloride
ANDA #214879
Succinylcholine Chloride Injectable; Injection ORIG-1 Micro Labs Approved
Testosterone
ANDA #213922
Testosterone Unknown ORIG-1 Aleor Dermaceuticals Tentative Approval
Valcyte
NDA #021304
Valganciclovir Hydrochloride Tablet; Oral SUPPL-16 Hoffmann La Roche Labeling Approved
Valcyte
NDA #022257
Valganciclovir Hydrochloride For Solution; Oral SUPPL-11 Hoffmann La Roche Labeling Approved
Ziagen
NDA #020977
Abacavir Sulfate Tablet; Oral SUPPL-35 Viiv Hlthcare Labeling Approved
Ziagen
NDA #020978
Abacavir Sulfate Solution; Oral SUPPL-38 Viiv Hlthcare Labeling Approved
Zolpidem Tartrate
ANDA #077359
Zolpidem Tartrate Tablet; Oral SUPPL-10 Sun Pharm Inds Inc Labeling Approved
Zolpidem Tartrate
ANDA #077359
Zolpidem Tartrate Tablet; Oral SUPPL-9 Sun Pharm Inds Inc Labeling Approved
Zolpidem Tartrate
ANDA #077359
Zolpidem Tartrate Tablet; Oral SUPPL-10 Sun Pharm Inds Inc Labeling Approved

November 23, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bexarotene
ANDA #209861
Bexarotene Capsule; Oral SUPPL-3 Ani Pharms Inc Labeling Approved
Cefazolin and Dextrose
NDA #050779
Cefazolin Sodium Injectable; Injection SUPPL-27 B Braun Efficacy Approved
Cosopt
NDA #020869
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-42 Akorn Labeling Approved
Decitabine
ANDA #205539
Decitabine Injectable; Intravenous ORIG-1 Apotex Approved
Dexmedetomidine Hydrochloride
ANDA #212857
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Tagi Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #206894
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Cipla Labeling Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #206894
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Cipla Labeling Approved
Fusilev
NDA #020140
Levoleucovorin Calcium Powder; Intravenous SUPPL-26 Acrotech Labeling Approved
Fusilev
NDA #020140
Levoleucovorin Calcium Solution; Intravenous SUPPL-26 Acrotech Labeling Approved
Nplate
BLA #125268
Romiplostim Injectable; Subcutaneous SUPPL-169 Amgen Labeling Approved
Nuplazid
NDA #207318
Pimavanserin Tartrate Tablet; Oral SUPPL-10 Acadia Pharms Inc Labeling Approved
Nuplazid
NDA #210793
Pimavanserin Tartrate Capsule; Oral SUPPL-7 Acadia Pharms Inc Labeling Approved
Oxlumo
NDA #214103
Lumasiran Solution; Subcutaneous ORIG-1 Alnylam Pharms Inc Type 1 - New Molecular Entity Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Unknown ORIG-1 Xiamen Lp Pharm Co Tentative Approval
Tadalafil
ANDA #213496
Tadalafil Tablet; Oral ORIG-1 Sunshine Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-10 Genentech Inc Efficacy Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-4 Genentech Inc Efficacy Approved
Xofluza
NDA #214410
Baloxavir Marboxil Suspension; Oral ORIG-1 Genentech Inc Type 3 - New Dosage Form Approved
Xofluza
NDA #214410
Baloxavir Marboxil Tablet; Oral ORIG-1 Genentech Inc Type 3 - New Dosage Form Approved

November 20, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #208327
Abiraterone Acetate Tablet; Oral SUPPL-10 Amneal Pharms Labeling Approved
Abiraterone Acetate
ANDA #208327
Abiraterone Acetate Tablet; Oral SUPPL-10 Amneal Pharms Labeling Approved
Atropen
NDA #017106
Atropine Solution; Intramuscular SUPPL-52 Meridian Medcl Techn Labeling Approved
Atropen
NDA #017106
Atropine Solution; Intramuscular SUPPL-52 Meridian Medcl Techn Labeling Approved
Blenrep
BLA #761158
Belantamab Mafodotin-Blmf Injectable; Intravenous SUPPL-3 Glaxosmithkline REMS Approved
Dextrose 5% In Plastic Container
ANDA #207449
Dextrose Injectable; Injection SUPPL-14 Fresenius Kabi Usa Manufacturing (CMC) Approved
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-4 Janssen Biotech Efficacy Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-10 Dexcel Pharma Labeling Approved
Palynziq
BLA #761079
Pegvaliase-Pqpz Injectable; Injection SUPPL-10 Biomarin Pharm Labeling Approved
Pomalyst
NDA #204026
Pomalidomide Capsule; Oral SUPPL-27 Celgene Efficacy Approved
Prednisone
ANDA #209727
Prednisone Tablet; Oral ORIG-1 Strides Pharma Approved
Sevelamer Carbonate
ANDA #211316
Sevelamer Carbonate For Suspension; Oral ORIG-1 Impax Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-434 Alexion Pharm Labeling Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-434 Alexion Pharm Labeling Approved
Succinylcholine Chloride
ANDA #211346
Succinylcholine Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Temodar
NDA #021029
Temozolomide Capsule; Oral SUPPL-35 Merck Sharp Dohme Labeling Approved
Temodar
NDA #022277
Temozolomide Powder; Intravenous SUPPL-14 Merck Sharp Dohme Labeling Approved
Victoza
NDA #022341
Liraglutide Recombinant Solution; Subcutaneous SUPPL-36 Novo Nordisk Inc Labeling Approved
Victoza
NDA #022341
Liraglutide Recombinant Solution; Subcutaneous SUPPL-36 Novo Nordisk Inc Labeling Approved
Zokinvy
NDA #213969
Lonafarnib Capsule; Oral ORIG-1 Eiger Biopharms Type 1 - New Molecular Entity Approved

November 19, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Canagliflozin; Metformin Hydrochloride
ANDA #210481
Canagliflozin;Metformin Hydrochloride Unknown ORIG-1 Sandoz Inc Tentative Approval
Dolutegravir
NDA #214521
Dolutegravir Tablet; Oral ORIG-1 Mylan Labs Ltd Type 3 - New Dosage Form Tentative Approval
Sodium Chloride 0.9% In Plastic Container
ANDA #207310
Sodium Chloride Injectable; Injection SUPPL-12 Fresenius Kabi Usa Manufacturing (CMC) Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-23 Abbvie Inc Labeling Approved

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