Drugs@FDA: FDA Approved Drug Products
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.
September 13, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Anastrozole
ANDA #091051 |
Anastrozole | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Anastrozole
ANDA #091051 |
Anastrozole | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Benlysta
BLA #125370 |
Belimumab | Injectable; Injection | SUPPL-67 | Human Genome Sciences Inc. | Labeling | Approved |
| Benlysta
BLA #761043 |
Belimumab | Injectable; Injection | SUPPL-5 | Glaxosmithkline Llc | Labeling | Approved |
| Cyltezo
BLA #761058 |
Adalimumab-Adbm | Injectable; Injection | SUPPL-3 | Boehringer Ingelheim | Labeling | Approved |
| Dolutegravir Sodium
ANDA #212179 |
Dolutegravir Sodium | Unknown | ORIG-1 | Micro Labs Ltd | Tentative Approval | |
| Valsartan
ANDA #091367 |
Valsartan | Tablet; Oral | SUPPL-5 | Alembic Pharms Ltd | Labeling | Approved |
| Valsartan
ANDA #091367 |
Valsartan | Tablet; Oral | SUPPL-11 | Alembic Pharms Ltd | Labeling | Approved |
| Valsartan
ANDA #091367 |
Valsartan | Tablet; Oral | SUPPL-11 | Alembic Pharms Ltd | Labeling | Approved |
| Zulresso
NDA #211371 |
Brexanolone | Solution; Intravenous | SUPPL-2 | Sage Therap | Labeling | Approved |
September 12, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-3 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Ditropan Xl
NDA #020897 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-37 | Janssen Pharms | Labeling | Approved |
| Ibsrela
NDA #211801 |
Tenapanor | Tablet; Oral | ORIG-1 | Ardelyx Inc | Type 1 - New Molecular Entity | Approved |
| Nucala
BLA #125526 |
Mepolizumab | Injectable; Subcutaneous Lyophilized Power | SUPPL-12 | Glaxosmithkline Llc | Efficacy | Approved |
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-3 | Glaxosmithkline | Efficacy | Approved |
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-2 | Glaxosmithkline | Labeling | Approved |
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-2 | Glaxosmithkline | Labeling | Approved |
| Sabril
NDA #020427 |
Vigabatrin | Tablet; Oral | SUPPL-22 | Lundbeck Pharms Llc | REMS | Approved |
| Sabril
NDA #022006 |
Vigabatrin | For Solution; Oral | SUPPL-24 | Lundbeck Pharms Llc | REMS | Approved |
| Vigabatrin
ANDA #208218 |
Vigabatrin | For Solution; Oral | SUPPL-7 | Par Pharm Inc | REMS | Approved |
| Vigabatrin
ANDA #209822 |
Vigabatrin | Tablet; Oral | SUPPL-4 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin
ANDA #209824 |
Vigabatrin | For Solution; Oral | SUPPL-5 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin
ANDA #210155 |
Vigabatrin | For Solution; Oral | SUPPL-4 | Amneal Pharms | REMS | Approved |
| Vigabatrin
ANDA #211481 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Dr Reddys Labs Ltd | REMS | Approved |
| Vigadrone
ANDA #210196 |
Vigabatrin | For Solution; Oral | SUPPL-3 | Aucta | REMS | Approved |
September 11, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride
ANDA #071293 |
Amantadine Hydrochloride | Capsule; Oral | SUPPL-40 | Sandoz | Manufacturing (CMC) | Approved |
| Amantadine Hydrochloride
ANDA #071293 |
Amantadine Hydrochloride | Capsule; Oral | SUPPL-38 | Sandoz | Labeling | Approved |
| Dapagliflozin
ANDA #211482 |
Dapagliflozin | Unknown | ORIG-1 | Ajanta Pharma Ltd | Tentative Approval | |
| Dolutegavir; Lamivudine; Tenofovir Alafenamide Fumarate
NDA #210865 |
Dolutegavir;Lamivudine;Tenofovir Alafenamide Fumarate | Unknown | ORIG-1 | Mylan Labs Ltd | Type 4 - New Combination | Tentative Approval |
| Famotidine
ANDA #206531 |
Famotidine | Tablet; Oral | SUPPL-1 | Aurobindo Pharma Ltd | Labeling | Approved |
| Famotidine
ANDA #206531 |
Famotidine | Tablet; Oral | SUPPL-7 | Aurobindo Pharma Ltd | Labeling | Approved |
| Famotidine
ANDA #206531 |
Famotidine | Tablet; Oral | SUPPL-7 | Aurobindo Pharma Ltd | Labeling | Approved |
| Indomethacin
ANDA #073314 |
Indomethacin | Suppository; Rectal | SUPPL-22 | Acp Nimble | Labeling | Approved |
| Indomethacin
ANDA #073314 |
Indomethacin | Suppository; Rectal | SUPPL-22 | Acp Nimble | Labeling | Approved |
| Indomethacin
ANDA #073314 |
Indomethacin | Suppository; Rectal | SUPPL-23 | Acp Nimble | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065379 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065379 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065379 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065416 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065451 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065451 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-25 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065521 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065521 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-18 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065521 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090253 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-9 | Dr Reddys Labs Ltd | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-9 | Dr Reddys Labs Ltd | Labeling | Approved |
| Paxil Cr
NDA #020936 |
Paroxetine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-47 | Apotex Technologies | Labeling | Approved |
September 10, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aczone
NDA #207154 |
Dapsone | Gel; Topical | SUPPL-4 | Almirall | Efficacy | Approved |
| Aczone
NDA #207154 |
Dapsone | Gel; Topical | SUPPL-4 | Almirall | Efficacy | Approved |
| Altabax
NDA #022055 |
Retapamulin | Ointment; Topical | SUPPL-7 | Almirall | Labeling | Approved |
| Apixaban
ANDA #209944 |
Apixaban | Tablet; Oral | ORIG-1 | Sunshine Lake | Tentative Approval | |
| Gvoke
NDA #212097 |
Glucagon | Injectable; Injection | ORIG-1 | Xeris Pharma Inc | Type 3 - New Dosage Form | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-18 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-18 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #091249 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-14 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #091249 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-14 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #091249 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #200197 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-11 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #200197 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-11 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #200197 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-13 | Alkem Labs Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #201662 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-19 | Alembic Pharms Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #201662 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-19 | Alembic Pharms Ltd | Labeling | Approved |
| Vortioxetine
ANDA #210953 |
Vortioxetine | Unknown | ORIG-1 | Amneal Pharms Co | Tentative Approval |
September 9, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
ANDA #201537 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-8 | Dr Reddys | Labeling | Approved |
| Celecoxib
ANDA #206827 |
Celecoxib | Capsule; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Celecoxib
ANDA #206827 |
Celecoxib | Capsule; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205397 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | ORIG-1 | Perrigo Israel | Approved | |
| Glucagon
NDA #201849 |
Glucagon Hydrochloride | Powder; Intramuscular, Intravenous | SUPPL-5 | Fresenius Kabi Usa | Efficacy | Approved |
| Hydrocodone Bitartrate and Acetaminophen
ANDA #203863 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Hydrocodone Bitartrate and Acetaminophen
ANDA #203863 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-11 | Pfizer Inc | Efficacy | Approved |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-12 | Pfizer Inc | Labeling | Approved |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-12 | Pfizer Inc | Labeling | Approved |
| Kisqali
NDA #209092 |
Ribociclib Succinate | Tablet; Oral | SUPPL-4 | Novartis Pharms Corp | Labeling | Approved |
| Kisqali Femara Co-Pack (Copackaged)
NDA #209935 |
Letrozole; Ribociclib Succinate | Tablet, Tablet; Oral | SUPPL-7 | Novartis Pharms Corp | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-1 | Lupin Atlantis | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-1 | Lupin Atlantis | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-6 | Lupin Atlantis | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Oxybutynin Chloride
ANDA #078503 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-7 | Osmotica Pharm Us | Labeling | Approved |
| Oxybutynin Chloride
ANDA #078503 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-9 | Osmotica Pharm Us | Labeling | Approved |
| Pravastatin Sodium
ANDA #076397 |
Pravastatin Sodium | Tablet; Oral | SUPPL-7 | Apnar Pharma Lp | Labeling | Approved |
| Pravastatin Sodium
ANDA #077491 |
Pravastatin Sodium | Tablet; Oral | SUPPL-5 | Apnar Pharma Lp | Labeling | Approved |
| Prochlorperazine Edisylate
ANDA #204147 |
Prochlorperazine Edisylate | Injectable; Injection | SUPPL-21 | Emcure Pharms Ltd | Manufacturing (CMC) | Approved |
| Prochlorperazine Edisylate
ANDA #204147 |
Prochlorperazine Edisylate | Injectable; Injection | SUPPL-21 | Emcure Pharms Ltd | Manufacturing (CMC) | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-11 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-6 | Cubist Pharms Llc | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #078225 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-14 | Zydus Pharms Usa Inc | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #078225 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-14 | Zydus Pharms Usa Inc | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #090931 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-10 | Sun Pharm Inds Ltd | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #090931 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-10 | Sun Pharm Inds Ltd | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #202433 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-12 | Aurobindo Pharma Ltd | Labeling | Approved |
| Telmisartan and Amlodipine
ANDA #202516 |
Amlodipine Besylate; Telmisartan | Tablet; Oral | SUPPL-4 | Mylan | Labeling | Approved |
| Telmisartan and Amlodipine
ANDA #202516 |
Amlodipine Besylate; Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Telmisartan and Amlodipine
ANDA #202516 |
Amlodipine Besylate; Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Tramadol Hydrochloride
ANDA #201384 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Sun Pharm | Labeling | Approved |
| Tramadol Hydrochloride
ANDA #201384 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Sun Pharm | Labeling | Approved |
| Verzenio
NDA #208716 |
Abemaciclib | Tablet; Oral | SUPPL-3 | Eli Lilly and Co | Labeling | Approved |
| Verzenio
NDA #208716 |
Abemaciclib | Tablet; Oral | SUPPL-3 | Eli Lilly and Co | Labeling | Approved |
September 13, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Anastrozole
ANDA #091051 |
Anastrozole | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Anastrozole
ANDA #091051 |
Anastrozole | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Benlysta
BLA #125370 |
Belimumab | Injectable; Injection | SUPPL-67 | Human Genome Sciences Inc. | Labeling | Approved |
| Benlysta
BLA #761043 |
Belimumab | Injectable; Injection | SUPPL-5 | Glaxosmithkline Llc | Labeling | Approved |
| Cyltezo
BLA #761058 |
Adalimumab-Adbm | Injectable; Injection | SUPPL-3 | Boehringer Ingelheim | Labeling | Approved |
| Dolutegravir Sodium
ANDA #212179 |
Dolutegravir Sodium | Unknown | ORIG-1 | Micro Labs Ltd | Tentative Approval | |
| Valsartan
ANDA #091367 |
Valsartan | Tablet; Oral | SUPPL-5 | Alembic Pharms Ltd | Labeling | Approved |
| Valsartan
ANDA #091367 |
Valsartan | Tablet; Oral | SUPPL-11 | Alembic Pharms Ltd | Labeling | Approved |
| Valsartan
ANDA #091367 |
Valsartan | Tablet; Oral | SUPPL-11 | Alembic Pharms Ltd | Labeling | Approved |
| Zulresso
NDA #211371 |
Brexanolone | Solution; Intravenous | SUPPL-2 | Sage Therap | Labeling | Approved |
September 12, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-3 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #203751 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Ditropan Xl
NDA #020897 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-37 | Janssen Pharms | Labeling | Approved |
| Ibsrela
NDA #211801 |
Tenapanor | Tablet; Oral | ORIG-1 | Ardelyx Inc | Type 1 - New Molecular Entity | Approved |
| Nucala
BLA #125526 |
Mepolizumab | Injectable; Subcutaneous Lyophilized Power | SUPPL-12 | Glaxosmithkline Llc | Efficacy | Approved |
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-3 | Glaxosmithkline | Efficacy | Approved |
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-2 | Glaxosmithkline | Labeling | Approved |
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-2 | Glaxosmithkline | Labeling | Approved |
| Sabril
NDA #020427 |
Vigabatrin | Tablet; Oral | SUPPL-22 | Lundbeck Pharms Llc | REMS | Approved |
| Sabril
NDA #022006 |
Vigabatrin | For Solution; Oral | SUPPL-24 | Lundbeck Pharms Llc | REMS | Approved |
| Vigabatrin
ANDA #208218 |
Vigabatrin | For Solution; Oral | SUPPL-7 | Par Pharm Inc | REMS | Approved |
| Vigabatrin
ANDA #209822 |
Vigabatrin | Tablet; Oral | SUPPL-4 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin
ANDA #209824 |
Vigabatrin | For Solution; Oral | SUPPL-5 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin
ANDA #210155 |
Vigabatrin | For Solution; Oral | SUPPL-4 | Amneal Pharms | REMS | Approved |
| Vigabatrin
ANDA #211481 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Dr Reddys Labs Ltd | REMS | Approved |
| Vigadrone
ANDA #210196 |
Vigabatrin | For Solution; Oral | SUPPL-3 | Aucta | REMS | Approved |
September 11, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride
ANDA #071293 |
Amantadine Hydrochloride | Capsule; Oral | SUPPL-40 | Sandoz | Manufacturing (CMC) | Approved |
| Amantadine Hydrochloride
ANDA #071293 |
Amantadine Hydrochloride | Capsule; Oral | SUPPL-38 | Sandoz | Labeling | Approved |
| Dapagliflozin
ANDA #211482 |
Dapagliflozin | Unknown | ORIG-1 | Ajanta Pharma Ltd | Tentative Approval | |
| Dolutegavir; Lamivudine; Tenofovir Alafenamide Fumarate
NDA #210865 |
Dolutegavir;Lamivudine;Tenofovir Alafenamide Fumarate | Unknown | ORIG-1 | Mylan Labs Ltd | Type 4 - New Combination | Tentative Approval |
| Famotidine
ANDA #206531 |
Famotidine | Tablet; Oral | SUPPL-1 | Aurobindo Pharma Ltd | Labeling | Approved |
| Famotidine
ANDA #206531 |
Famotidine | Tablet; Oral | SUPPL-7 | Aurobindo Pharma Ltd | Labeling | Approved |
| Famotidine
ANDA #206531 |
Famotidine | Tablet; Oral | SUPPL-7 | Aurobindo Pharma Ltd | Labeling | Approved |
| Indomethacin
ANDA #073314 |
Indomethacin | Suppository; Rectal | SUPPL-22 | Acp Nimble | Labeling | Approved |
| Indomethacin
ANDA #073314 |
Indomethacin | Suppository; Rectal | SUPPL-22 | Acp Nimble | Labeling | Approved |
| Indomethacin
ANDA #073314 |
Indomethacin | Suppository; Rectal | SUPPL-23 | Acp Nimble | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065379 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065379 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065379 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065416 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065451 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065451 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-25 | Sandoz | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065520 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-22 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065521 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065521 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-18 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065521 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090253 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-9 | Dr Reddys Labs Ltd | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Oxaprozin
ANDA #075855 |
Oxaprozin | Tablet; Oral | SUPPL-9 | Dr Reddys Labs Ltd | Labeling | Approved |
| Paxil Cr
NDA #020936 |
Paroxetine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-47 | Apotex Technologies | Labeling | Approved |
September 10, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aczone
NDA #207154 |
Dapsone | Gel; Topical | SUPPL-4 | Almirall | Efficacy | Approved |
| Aczone
NDA #207154 |
Dapsone | Gel; Topical | SUPPL-4 | Almirall | Efficacy | Approved |
| Altabax
NDA #022055 |
Retapamulin | Ointment; Topical | SUPPL-7 | Almirall | Labeling | Approved |
| Apixaban
ANDA #209944 |
Apixaban | Tablet; Oral | ORIG-1 | Sunshine Lake | Tentative Approval | |
| Gvoke
NDA #212097 |
Glucagon | Injectable; Injection | ORIG-1 | Xeris Pharma Inc | Type 3 - New Dosage Form | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-18 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #065491 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-18 | Teva Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #091249 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-14 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #091249 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-14 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #091249 |
Mycophenolate Mofetil | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #200197 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-11 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #200197 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-11 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #200197 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-13 | Alkem Labs Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #201662 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-19 | Alembic Pharms Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #201662 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-19 | Alembic Pharms Ltd | Labeling | Approved |
| Vortioxetine
ANDA #210953 |
Vortioxetine | Unknown | ORIG-1 | Amneal Pharms Co | Tentative Approval |
September 9, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
ANDA #201537 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-8 | Dr Reddys | Labeling | Approved |
| Celecoxib
ANDA #206827 |
Celecoxib | Capsule; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Celecoxib
ANDA #206827 |
Celecoxib | Capsule; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205397 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | ORIG-1 | Perrigo Israel | Approved | |
| Glucagon
NDA #201849 |
Glucagon Hydrochloride | Powder; Intramuscular, Intravenous | SUPPL-5 | Fresenius Kabi Usa | Efficacy | Approved |
| Hydrocodone Bitartrate and Acetaminophen
ANDA #203863 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Hydrocodone Bitartrate and Acetaminophen
ANDA #203863 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-11 | Pfizer Inc | Efficacy | Approved |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-12 | Pfizer Inc | Labeling | Approved |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-12 | Pfizer Inc | Labeling | Approved |
| Kisqali
NDA #209092 |
Ribociclib Succinate | Tablet; Oral | SUPPL-4 | Novartis Pharms Corp | Labeling | Approved |
| Kisqali Femara Co-Pack (Copackaged)
NDA #209935 |
Letrozole; Ribociclib Succinate | Tablet, Tablet; Oral | SUPPL-7 | Novartis Pharms Corp | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-1 | Lupin Atlantis | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-1 | Lupin Atlantis | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-6 | Lupin Atlantis | Labeling | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Mibelas 24 Fe
ANDA #206287 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet, Chewable; Oral | SUPPL-8 | Lupin Atlantis | Manufacturing (CMC) | Approved |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Oxybutynin Chloride
ANDA #078503 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-7 | Osmotica Pharm Us | Labeling | Approved |
| Oxybutynin Chloride
ANDA #078503 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-9 | Osmotica Pharm Us | Labeling | Approved |
| Pravastatin Sodium
ANDA #076397 |
Pravastatin Sodium | Tablet; Oral | SUPPL-7 | Apnar Pharma Lp | Labeling | Approved |
| Pravastatin Sodium
ANDA #077491 |
Pravastatin Sodium | Tablet; Oral | SUPPL-5 | Apnar Pharma Lp | Labeling | Approved |
| Prochlorperazine Edisylate
ANDA #204147 |
Prochlorperazine Edisylate | Injectable; Injection | SUPPL-21 | Emcure Pharms Ltd | Manufacturing (CMC) | Approved |
| Prochlorperazine Edisylate
ANDA #204147 |
Prochlorperazine Edisylate | Injectable; Injection | SUPPL-21 | Emcure Pharms Ltd | Manufacturing (CMC) | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Raloxifene Hydrochloride
ANDA #078193 |
Raloxifene Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-11 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-6 | Cubist Pharms Llc | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #078225 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-14 | Zydus Pharms Usa Inc | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #078225 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-14 | Zydus Pharms Usa Inc | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #090931 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-10 | Sun Pharm Inds Ltd | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #090931 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-10 | Sun Pharm Inds Ltd | Labeling | Approved |
| Tamsulosin Hydrochloride
ANDA #202433 |
Tamsulosin Hydrochloride | Capsule; Oral | SUPPL-12 | Aurobindo Pharma Ltd | Labeling | Approved |
| Telmisartan and Amlodipine
ANDA #202516 |
Amlodipine Besylate; Telmisartan | Tablet; Oral | SUPPL-4 | Mylan | Labeling | Approved |
| Telmisartan and Amlodipine
ANDA #202516 |
Amlodipine Besylate; Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Telmisartan and Amlodipine
ANDA #202516 |
Amlodipine Besylate; Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Tramadol Hydrochloride
ANDA #201384 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Sun Pharm | Labeling | Approved |
| Tramadol Hydrochloride
ANDA #201384 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Sun Pharm | Labeling | Approved |
| Verzenio
NDA #208716 |
Abemaciclib | Tablet; Oral | SUPPL-3 | Eli Lilly and Co | Labeling | Approved |
| Verzenio
NDA #208716 |
Abemaciclib | Tablet; Oral | SUPPL-3 | Eli Lilly and Co | Labeling | Approved |
September 6, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Advil Allergy and Congestion Relief
NDA #022113 |
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride | Tablet; Oral | SUPPL-8 | Pfizer | Labeling | Approved |
| Advil Multi-Symptom Cold & Flu
NDA #022113 |
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride | Tablet; Oral | SUPPL-8 | Pfizer | Labeling | Approved |
| Aubagio
NDA #202992 |
Teriflunomide | Tablet; Oral | SUPPL-8 | Sanofi Aventis Us | Labeling | Approved |
| Aubagio
NDA #202992 |
Teriflunomide | Tablet; Oral | SUPPL-8 | Sanofi Aventis Us | Labeling | Approved |
| Cimzia
BLA #125160 |
Certolizumab Pegol | Injectable; Injection | SUPPL-293 | Ucb Inc | Labeling | Approved |
| Clobetasol Propionate
ANDA #074248 |
Clobetasol Propionate | Ointment; Topical | SUPPL-24 | Taro | Labeling | Approved |
| Clobetasol Propionate
ANDA #075279 |
Clobetasol Propionate | Gel; Topical | SUPPL-13 | Taro | Labeling | Approved |
| Clobetasol Propionate
ANDA #075391 |
Clobetasol Propionate | Solution; Topical | SUPPL-12 | Fougera Pharms | Labeling | Approved |
| Clobetasol Propionate
ANDA #076977 |
Clobetasol Propionate | Solution; Topical | SUPPL-11 | Tolmar | Labeling | Approved |
| Clobetasol Propionate
ANDA #090898 |
Clobetasol Propionate | Spray; Topical | SUPPL-4 | Paddock Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #090898 |
Clobetasol Propionate | Spray; Topical | SUPPL-6 | Paddock Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #090974 |
Clobetasol Propionate | Shampoo; Topical | SUPPL-5 | Perrigo Israel | Labeling | Approved |
| Clobetasol Propionate
ANDA #200302 |
Clobetasol Propionate | Lotion; Topical | SUPPL-2 | Taro | Labeling | Approved |
| Clobetasol Propionate
ANDA #201402 |
Clobetasol Propionate | Aerosol, Foam; Topical | SUPPL-2 | Perrigo Uk Finco | Labeling | Approved |
| Clobetasol Propionate
ANDA #201402 |
Clobetasol Propionate | Aerosol, Foam; Topical | SUPPL-13 | Perrigo Uk Finco | Labeling | Approved |
| Clobetasol Propionate
ANDA #206378 |
Clobetasol Propionate | Spray; Topical | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Clobetasol Propionate
ANDA #206805 |
Clobetasol Propionate | Aerosol, Foam; Topical | SUPPL-1 | Ingenus Pharms Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #206805 |
Clobetasol Propionate | Aerosol, Foam; Topical | SUPPL-1 | Ingenus Pharms Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #208125 |
Clobetasol Propionate | Spray; Topical | SUPPL-1 | Lupin Ltd | Labeling | Approved |
| Clobetasol Propionate
ANDA #208667 |
Clobetasol Propionate | Lotion; Topical | SUPPL-1 | Teligent Pharma Inc | Labeling | Approved |
| Docetaxel
ANDA #207563 |
Docetaxel | Injectable; Injection | SUPPL-2 | Ingenus Pharms Llc | Labeling | Approved |
| Docetaxel
ANDA #207563 |
Docetaxel | Injectable; Injection | SUPPL-4 | Ingenus Pharms Llc | Labeling | Approved |
| Meropenem
ANDA #204139 |
Meropenem | Injectable; Injection | SUPPL-1 | Acs Dobfar Spa | Labeling | Approved |
| Mesna
ANDA #075764 |
Mesna | Injectable; Intravenous | SUPPL-28 | Teva Pharms Usa | Labeling | Approved |
| Mesna
ANDA #075764 |
Mesna | Injectable; Intravenous | SUPPL-28 | Teva Pharms Usa | Labeling | Approved |
| Mesna
ANDA #206992 |
Mesna | Injectable; Intravenous | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Mesna
ANDA #206992 |
Mesna | Injectable; Intravenous | SUPPL-3 | Gland Pharma Ltd | Labeling | Approved |
| Ofev
NDA #205832 |
Nintedanib Esylate | Capsule; Oral | SUPPL-12 | Boehringer Ingelheim | Efficacy | Approved |
| Pulmicort Flexhaler
NDA #021949 |
Budesonide | Powder, Metered; Inhalation | SUPPL-13 | Astrazeneca | Labeling | Approved |
| Pulmicort Respules
NDA #020929 |
Budesonide | Suspension; Inhalation | SUPPL-52 | Astrazeneca Pharms | Labeling | Approved |
| Temazepam
ANDA #071427 |
Temazepam | Capsule; Oral | SUPPL-30 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071427 |
Temazepam | Capsule; Oral | SUPPL-31 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071427 |
Temazepam | Capsule; Oral | SUPPL-30 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071427 |
Temazepam | Capsule; Oral | SUPPL-31 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071428 |
Temazepam | Capsule; Oral | SUPPL-30 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071428 |
Temazepam | Capsule; Oral | SUPPL-30 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071428 |
Temazepam | Capsule; Oral | SUPPL-31 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071428 |
Temazepam | Capsule; Oral | SUPPL-30 | Sandoz | Labeling | Approved |
| Temazepam
ANDA #071428 |
Temazepam | Capsule; Oral | SUPPL-31 | Sandoz | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078020 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-13 | Mylan Pharms Inc | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078020 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-13 | Mylan Pharms Inc | Labeling | Approved |
| Vivitrol
NDA #021897 |
Naltrexone | For Suspension, Extended Release; Intramuscular | SUPPL-45 | Alkermes | Labeling | Approved |
| Vivitrol
NDA #021897 |
Naltrexone | For Suspension, Extended Release; Intramuscular | SUPPL-45 | Alkermes | Labeling | Approved |
| Vivitrol
NDA #021897 |
Naltrexone | For Suspension, Extended Release; Intramuscular | SUPPL-45 | Alkermes | Labeling | Approved |
September 5, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Anastrozole
ANDA #078921 |
Anastrozole | Tablet; Oral | SUPPL-8 | Zydus Pharms Usa Inc | Labeling | Approved |
| Anastrozole
ANDA #078921 |
Anastrozole | Tablet; Oral | SUPPL-8 | Zydus Pharms Usa Inc | Labeling | Approved |
| Asparlas
BLA #761102 |
Calaspargase Pegol-Mknl | Injectable; Intravenous | SUPPL-2 | Servier Pharma Llc | Labeling | Approved |
| Busulfan
ANDA #205184 |
Busulfan | Injectable; Injection | SUPPL-1 | Mylan Labs Ltd | Labeling | Approved |
| Caspofungin Acetate
ANDA #207092 |
Caspofungin Acetate | Powder; Intravenous | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Caspofungin Acetate
ANDA #207092 |
Caspofungin Acetate | Powder; Intravenous | SUPPL-3 | Gland Pharma Ltd | Labeling | Approved |
| Clinda-Derm
ANDA #063329 |
Clindamycin Phosphate | Solution; Topical | SUPPL-6 | Paddock Llc | Labeling | Approved |
| Docetaxel
ANDA #208859 |
Docetaxel | Injectable; Injection | SUPPL-2 | Mylan Labs Ltd | Labeling | Approved |
| Docetaxel
ANDA #210072 |
Docetaxel | Injectable; Injection | SUPPL-3 | Mylan Labs Ltd | Labeling | Approved |
| Docetaxel
ANDA #210848 |
Docetaxel | Injectable; Injection | SUPPL-2 | Mylan Labs Ltd | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #202410 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-1 | Hisun Pharm Hangzhou | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #202410 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-1 | Hisun Pharm Hangzhou | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #202656 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #202656 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Doxycycline Hyclate
ANDA #207289 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-3 | Amneal Pharms | Labeling | Approved |
| Doxycycline Hyclate
ANDA #207289 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-1 | Amneal Pharms | Labeling | Approved |
| Doxycycline Hyclate
ANDA #207289 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-3 | Amneal Pharms | Labeling | Approved |
| Doxycycline Hyclate
ANDA #207289 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-6 | Amneal Pharms | Labeling | Approved |
| Doxycycline Hyclate
ANDA #207774 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Doxycycline Hyclate
ANDA #207774 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Doxycycline Hyclate
ANDA #211012 |
Doxycycline Hyclate | Capsule; Oral | SUPPL-1 | Ajanta Pharma Ltd | Labeling | Approved |
| Fosaprepitant
NDA #210064 |
Fosaprepitant | Injectable; Injection | ORIG-1 | Teva Pharms Usa Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Fosaprepitant Dimeglumine
ANDA #209965 |
Fosaprepitant Dimeglumine | Powder; Intravenous | ORIG-1 | Msn Labs Pvt Ltd | Approved | |
| Fosaprepitant Dimeglumine
ANDA #210689 |
Fosaprepitant Dimeglumine | Powder; Intravenous | ORIG-1 | Lupin Ltd | Approved | |
| Metformin Hydrochloride
ANDA #091664 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-2 | Lupin Ltd | Labeling | Approved |
| Metformin Hydrochloride
ANDA #091664 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Lupin Ltd | Labeling | Approved |
| Metformin Hydrochloride
ANDA #091664 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Lupin Ltd | Labeling | Approved |
| Methylprednisolone
ANDA #040183 |
Methylprednisolone | Tablet; Oral | SUPPL-18 | Vintage Pharms | Labeling | Approved |
| Octreotide Acetate (Preservative Free)
ANDA #079198 |
Octreotide Acetate | Injectable; Injection | SUPPL-7 | Mylan Institutional | Labeling | Approved |
| Paragard T 380a
NDA #018680 |
Copper | Intrauterine Device; Intrauterine | SUPPL-70 | Coopersurgical | Labeling | Approved |
| Paragard T 380a
NDA #018680 |
Copper | Intrauterine Device; Intrauterine | SUPPL-69 | Coopersurgical | Labeling | Approved |
| Remeron
NDA #020415 |
Mirtazapine | Tablet; Oral | SUPPL-35 | Organon Usa Inc | Labeling | Approved |
| Remeron Soltab
NDA #021208 |
Mirtazapine | Tablet, Orally Disintegrating; Oral | SUPPL-25 | Organon Usa Inc | Labeling | Approved |
| Sulfamethoxazole and Trimethoprim
NDA #018598 |
Sulfamethoxazole; Trimethoprim | Tablet; Oral | SUPPL-52 | Fosun Pharma | Labeling | Approved |
| Sulfamethoxazole and Trimethoprim Double Strength
NDA #018598 |
Sulfamethoxazole; Trimethoprim | Tablet; Oral | SUPPL-52 | Fosun Pharma | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078946 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078946 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-6 | Lupin Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078946 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078946 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-6 | Lupin Ltd | Labeling | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #078946 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-7 | Lupin Ltd | Labeling | Approved |
September 4, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Glycopyrrolate
ANDA #089335 |
Glycopyrrolate | Injectable; Injection | SUPPL-23 | Am Regent | Labeling | Approved |
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container
NDA #019339 |
Heparin Sodium | Injectable; Injection | SUPPL-52 | Hospira | Labeling | Approved |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.9%
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container
NDA #019339 |
Heparin Sodium | Injectable; Injection | SUPPL-52 | Hospira | Labeling | Approved |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container
NDA #019805 |
Heparin Sodium | Injectable; Injection | SUPPL-34 | Hospira | Labeling | Approved |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container
NDA #019339 |
Heparin Sodium | Injectable; Injection | SUPPL-52 | Hospira | Labeling | Approved |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container
NDA #019805 |
Heparin Sodium | Injectable; Injection | SUPPL-34 | Hospira | Labeling | Approved |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.9%
NDA #018916 |
Heparin Sodium | Injectable; Injection | SUPPL-63 | Hospira | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208058 |
Lurasidone Hydrochloride | Tablet; Oral | ORIG-1 | Emcure Pharms Ltd | Approved | |
| Uptravi
NDA #207947 |
Selexipag | Tablet; Oral | SUPPL-7 | Actelion Pharms Ltd | Labeling | Approved |
| Valsartan
ANDA #202696 |
Valsartan | Tablet; Oral | SUPPL-13 | Macleods Pharms Ltd | Labeling | Approved |
| Valsartan
ANDA #202696 |
Valsartan | Tablet; Oral | SUPPL-13 | Macleods Pharms Ltd | Labeling | Approved |
September 3, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Losartan Potassium
ANDA #091129 |
Losartan Potassium | Tablet; Oral | SUPPL-8 | Watson Labs | Labeling | Approved |
| Losartan Potassium
ANDA #091129 |
Losartan Potassium | Tablet; Oral | SUPPL-8 | Watson Labs | Labeling | Approved |
| Losartan Potassium
ANDA #200290 |
Losartan Potassium | Tablet; Oral | SUPPL-3 | Ipca Labs Ltd | Labeling | Approved |
| Losartan Potassium
ANDA #200290 |
Losartan Potassium | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Losartan Potassium
ANDA #200290 |
Losartan Potassium | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Losartan Potassium and Hydrochlorothiazide
ANDA #090528 |
Hydrochlorothiazide; Losartan Potassium | Tablet; Oral | SUPPL-19 | Torrent Pharms | Labeling | Approved |
| Losartan Potassium and Hydrochlorothiazide
ANDA #090528 |
Hydrochlorothiazide; Losartan Potassium | Tablet; Oral | SUPPL-19 | Torrent Pharms | Labeling | Approved |
| Valsartan
ANDA #205347 |
Valsartan | Tablet; Oral | SUPPL-1 | Square Pharms Ltd | Labeling | Approved |
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