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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