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.
May 20, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apokyn
NDA #021264 |
Apomorphine Hydrochloride | Injectable; Subcutaneous | SUPPL-16 | Us Worldmeds | Labeling | Approved |
| Faslodex
NDA #021344 |
Fulvestrant | Injectable; Intramuscular | SUPPL-39 | Astrazeneca | Labeling | Approved |
May 17, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azelastine Hydrochloride
ANDA #091444 |
Azelastine Hydrochloride | Spray, Metered; Nasal | SUPPL-3 | West-Ward Pharms Int | Labeling | Approved |
| Azelastine Hydrochloride
ANDA #207610 |
Azelastine Hydrochloride | Spray, Metered; Nasal | ORIG-1 | Hi Tech | Approved | |
| Cinacalcet Hydrochloride
ANDA #210570 |
Cinacalcet Hydrochloride | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #211715 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | ORIG-1 | Sun Pharm Industries | Approved | |
| Imipenem and Cilastatin
ANDA #090825 |
Cilastatin Sodium; Imipenem | Powder; Intravenous | SUPPL-11 | Hospira Inc | Labeling | Approved |
| Imipenem and Cilastatin
ANDA #090825 |
Cilastatin Sodium; Imipenem | Powder; Intravenous | SUPPL-12 | Hospira Inc | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208060 |
Lurasidone Hydrochloride | Tablet; Oral | ORIG-1 | Teva Pharms Usa | Approved | |
| Micafungin Sodium
ANDA #207344 |
Micafungin Sodium | Injectable; Intravenous | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Nayzilam
NDA #211321 |
Midazolam | Spray; Nasal | ORIG-1 | Proximagen Llc | Type 3 - New Dosage Form | Approved |
| Orfadin
NDA #021232 |
Nitisinone | Capsule; Oral | SUPPL-23 | Swedish Orphan | Labeling | Approved |
| Orfadin
NDA #206356 |
Nitisinone | Suspension; Oral | SUPPL-6 | Swedish Orphan | Labeling | Approved |
| Plavix
NDA #020839 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-72 | Sanofi Aventis Us | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078295 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-8 | Sun Pharm Inds | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078295 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-8 | Sun Pharm Inds | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078327 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-11 | Aurobindo Pharma | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078327 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-11 | Aurobindo Pharma | Labeling | Approved |
| Telmisartan
ANDA #202397 |
Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Telmisartan
ANDA #202397 |
Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Telmisartan
ANDA #203867 |
Telmisartan | Tablet; Oral | SUPPL-7 | Sandoz Inc | Labeling | Approved |
| Telmisartan
ANDA #208605 |
Telmisartan | Tablet; Oral | SUPPL-1 | Cadila Pharms Ltd | Labeling | Approved |
| Zulresso
NDA #211371 |
Brexanolone | Injectable; Injection | SUPPL-1 | Sage Therapeutics | REMS | Approved |
May 16, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aggrastat
NDA #020912 |
Tirofiban Hydrochloride | Injectable; Injection | SUPPL-27 | Medicure | Labeling | Approved |
| Aggrastat
NDA #020912 |
Tirofiban Hydrochloride | Solution; Injection | SUPPL-27 | Medicure | Labeling | Approved |
| Aggrastat
NDA #020913 |
Tirofiban Hydrochloride | Injectable; Injection | SUPPL-26 | Medicure | Labeling | Approved |
| Children's Cetirizine Hydrochloride Allergy
ANDA #212266 |
Cetirizine Hydrochloride | Solution; Oral | ORIG-1 | Quagen | Approved | |
| Diclofenac Sodium
ANDA #211253 |
Diclofenac Sodium | Gel; Topical | ORIG-1 | Gage Development | Approved | |
| Docetaxel
ANDA #210327 |
Docetaxel | Injectable; Injection | ORIG-1 | Shilpa Medicare Ltd | Approved | |
| Fragmin
NDA #020287 |
Dalteparin Sodium | Injectable; Injection | SUPPL-72 | Pfizer Inc | Efficacy | Approved |
| Fragmin
NDA #020287 |
Dalteparin Sodium | Injectable; Subcutaneous | SUPPL-72 | Pfizer Inc | Efficacy | Approved |
| Gattex Kit
NDA #203441 |
Teduglutide Recombinant | Powder; Subcutaneous | SUPPL-13 | Nps Pharms Inc | Efficacy | Approved |
| Herzuma
BLA #761091 |
Trastuzumab-Pkrb | Injectable; Injection | SUPPL-1 | Celltrion Inc | Manufacturing (CMC) | Approved |
| Herzuma
BLA #761091 |
Trastuzumab-Pkrb | Injectable; Injection | SUPPL-2 | Celltrion Inc | Efficacy | Approved |
| Jornay Pm
NDA #209311 |
Methylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Ironshore Pharms | Labeling | Approved |
| Livalo
NDA #022363 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-15 | Kowa Co | Efficacy | Approved |
| Nevirapine
ANDA #203411 |
Nevirapine | Tablet, Extended Release; Oral | SUPPL-13 | Sandoz Inc | Efficacy | Approved |
| Rivaroxaban
ANDA #208549 |
Rivaroxaban | Unknown | ORIG-1 | Prinston Inc | Tentative Approval | |
| Testosterone
ANDA #204570 |
Testosterone | Gel, Metered; Transdermal | SUPPL-1 | Actavis Labs Ut Inc | Labeling | Approved |
| Testosterone
ANDA #204570 |
Testosterone | Gel, Metered; Transdermal | SUPPL-1 | Actavis Labs Ut Inc | Labeling | Approved |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-39 | Actelion Pharms Ltd | Labeling | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-5 | Actelion Pharms | Labeling | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-5 | Actelion Pharms | Labeling | Approved |
May 15, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Allopurinol
ANDA #071450 |
Allopurinol | Tablet; Oral | SUPPL-40 | Sun Pharm Industries | Labeling | Approved |
| Antara (Micronized)
NDA #021695 |
Fenofibrate | Capsule; Oral | SUPPL-20 | Lupin Atlantis | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #075753 |
Fenofibrate | Capsule; Oral | SUPPL-10 | Rhodes Pharms | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #075868 |
Fenofibrate | Capsule; Oral | SUPPL-20 | Impax Labs | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #202676 |
Fenofibrate | Capsule; Oral | SUPPL-5 | Mylan Pharms Inc | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #205566 |
Fenofibrate | Capsule; Oral | SUPPL-3 | Glenmark Pharms Ltd | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #207378 |
Fenofibrate | Capsule; Oral | SUPPL-4 | Invagen Pharms | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #207805 |
Fenofibrate | Capsule; Oral | SUPPL-8 | Austarpharma | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #209504 |
Fenofibrate | Capsule; Oral | SUPPL-4 | Amerigen Pharms Ltd | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #210705 |
Fenofibrate | Capsule; Oral | SUPPL-1 | Ajanta Pharma Ltd | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #210782 |
Fenofibrate | Capsule; Oral | SUPPL-1 | Torrent | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #210782 |
Fenofibrate | Capsule; Oral | SUPPL-1 | Torrent | Labeling | Approved |
| Fenoglide
NDA #022118 |
Fenofibrate | Tablet; Oral | SUPPL-10 | Salix | Labeling | Approved |
| Fibricor
NDA #022418 |
Fenofibric Acid | Tablet; Oral | SUPPL-15 | Athena | Labeling | Approved |
| Ibuprofen
ANDA #210149 |
Ibuprofen | Suspension; Oral | SUPPL-1 | Guardian Drug | Manufacturing (CMC) | Approved |
| Lipofen
NDA #021612 |
Fenofibrate | Capsule; Oral | SUPPL-20 | Cipher Pharms Inc | Labeling | Approved |
| Trelegy Ellipta
NDA #209482 |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-5 | Glaxosmithkline | Labeling | Approved |
| Triglide
NDA #021350 |
Fenofibrate | Tablet; Oral | SUPPL-22 | Skyepharma Ag | Labeling | Approved |
| Venclexta
NDA #208573 |
Venetoclax | Tablet; Oral | SUPPL-13 | Abbvie Inc | Efficacy | Approved |
| Zoledronic Acid
ANDA #208513 |
Zoledronic Acid | Injectable; Intravenous | ORIG-1 | Shilpa Medicare Ltd | Approved |
May 14, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albendazole
ANDA #211117 |
Albendazole | Tablet; Oral | ORIG-1 | Edenbridge Pharms | Approved | |
| Bavencio
BLA #761049 |
Avelumab | Injectable; Injection | SUPPL-6 | Emd Serono Inc | Efficacy | Approved |
| Edurant
NDA #202022 |
Rilpivirine Hydrochloride | Tablet; Oral | SUPPL-13 | Janssen Prods | Labeling | Approved |
| Fulvestrant
ANDA #205935 |
Fulvestrant | Injectable; Intramuscular | ORIG-1 | Sandoz Inc | Approved | |
| Gemzar
NDA #020509 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-82 | Lilly | Labeling | Approved |
| Glycopyrrolate
ANDA #211334 |
Glycopyrrolate | Injectable; Injection | ORIG-1 | Sandoz Inc | Approved | |
| Vasostrict
NDA #204485 |
Vasopressin | Solution; Intravenous | SUPPL-9 | Par Sterile Products | Labeling | Approved |
May 13, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-63 | Bayer | Labeling | Approved |
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-64 | Bayer | Labeling | Approved |
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-65 | Bayer | Labeling | Approved |
| Corlanor
NDA #206143 |
Ivabradine Hydrochloride | Tablet; Oral | SUPPL-7 | Amgen Inc | Labeling | Approved |
| Corlanor
NDA #206143 |
Ivabradine Hydrochloride | Tablet; Oral | SUPPL-7 | Amgen Inc | Labeling | Approved |
| Doxorubicin Hydrochloride
ANDA #206062 |
Doxorubicin Hydrochloride | Injectable; Injection | ORIG-1 | Hisun Pharm Hangzhou | Approved | |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-7 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-7 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #206872 |
Entecavir | Tablet; Oral | SUPPL-2 | Cipla | Labeling | Approved |
| Entecavir
ANDA #206872 |
Entecavir | Tablet; Oral | SUPPL-3 | Cipla | Labeling | Approved |
| Entecavir
ANDA #206872 |
Entecavir | Tablet; Oral | SUPPL-3 | Cipla | Labeling | Approved |
| Entecavir
ANDA #208721 |
Entecavir | Tablet; Oral | SUPPL-1 | Breckenridge Pharm | Labeling | Approved |
| Eylea
BLA #125387 |
Aflibercept | Injectable; Injection | SUPPL-61 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Fenofibrate (Micronized)
ANDA #209504 |
Fenofibrate | Capsule; Oral | SUPPL-2 | Amerigen Pharms Ltd | Labeling | Approved |
| Labetalol Hydrochloride
ANDA #211325 |
Labetalol Hydrochloride | Tablet; Oral | ORIG-1 | Cadila Pharms Ltd | Approved | |
| Neostigmine Methylsulfate
ANDA #212512 |
Neostigmine Methylsulfate | Solution; Intravenous | ORIG-1 | Be Pharms | Approved | |
| Odomzo
NDA #205266 |
Sonidegib Phosphate | Capsule; Oral | SUPPL-6 | Sun Pharma Global | Labeling | Approved |
| Risedronate Sodium
ANDA #205280 |
Risedronate Sodium | Tablet; Oral | ORIG-1 | Orchid Hlthcare | Approved |
May 20, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apokyn
NDA #021264 |
Apomorphine Hydrochloride | Injectable; Subcutaneous | SUPPL-16 | Us Worldmeds | Labeling | Approved |
| Faslodex
NDA #021344 |
Fulvestrant | Injectable; Intramuscular | SUPPL-39 | Astrazeneca | Labeling | Approved |
May 17, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azelastine Hydrochloride
ANDA #091444 |
Azelastine Hydrochloride | Spray, Metered; Nasal | SUPPL-3 | West-Ward Pharms Int | Labeling | Approved |
| Azelastine Hydrochloride
ANDA #207610 |
Azelastine Hydrochloride | Spray, Metered; Nasal | ORIG-1 | Hi Tech | Approved | |
| Cinacalcet Hydrochloride
ANDA #210570 |
Cinacalcet Hydrochloride | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #211715 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | ORIG-1 | Sun Pharm Industries | Approved | |
| Imipenem and Cilastatin
ANDA #090825 |
Cilastatin Sodium; Imipenem | Powder; Intravenous | SUPPL-11 | Hospira Inc | Labeling | Approved |
| Imipenem and Cilastatin
ANDA #090825 |
Cilastatin Sodium; Imipenem | Powder; Intravenous | SUPPL-12 | Hospira Inc | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208060 |
Lurasidone Hydrochloride | Tablet; Oral | ORIG-1 | Teva Pharms Usa | Approved | |
| Micafungin Sodium
ANDA #207344 |
Micafungin Sodium | Injectable; Intravenous | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Nayzilam
NDA #211321 |
Midazolam | Spray; Nasal | ORIG-1 | Proximagen Llc | Type 3 - New Dosage Form | Approved |
| Orfadin
NDA #021232 |
Nitisinone | Capsule; Oral | SUPPL-23 | Swedish Orphan | Labeling | Approved |
| Orfadin
NDA #206356 |
Nitisinone | Suspension; Oral | SUPPL-6 | Swedish Orphan | Labeling | Approved |
| Plavix
NDA #020839 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-72 | Sanofi Aventis Us | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078295 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-8 | Sun Pharm Inds | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078295 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-8 | Sun Pharm Inds | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078327 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-11 | Aurobindo Pharma | Labeling | Approved |
| Sumatriptan Succinate
ANDA #078327 |
Sumatriptan Succinate | Tablet; Oral | SUPPL-11 | Aurobindo Pharma | Labeling | Approved |
| Telmisartan
ANDA #202397 |
Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Telmisartan
ANDA #202397 |
Telmisartan | Tablet; Oral | SUPPL-6 | Mylan | Labeling | Approved |
| Telmisartan
ANDA #203867 |
Telmisartan | Tablet; Oral | SUPPL-7 | Sandoz Inc | Labeling | Approved |
| Telmisartan
ANDA #208605 |
Telmisartan | Tablet; Oral | SUPPL-1 | Cadila Pharms Ltd | Labeling | Approved |
| Zulresso
NDA #211371 |
Brexanolone | Injectable; Injection | SUPPL-1 | Sage Therapeutics | REMS | Approved |
May 16, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aggrastat
NDA #020912 |
Tirofiban Hydrochloride | Injectable; Injection | SUPPL-27 | Medicure | Labeling | Approved |
| Aggrastat
NDA #020912 |
Tirofiban Hydrochloride | Solution; Injection | SUPPL-27 | Medicure | Labeling | Approved |
| Aggrastat
NDA #020913 |
Tirofiban Hydrochloride | Injectable; Injection | SUPPL-26 | Medicure | Labeling | Approved |
| Children's Cetirizine Hydrochloride Allergy
ANDA #212266 |
Cetirizine Hydrochloride | Solution; Oral | ORIG-1 | Quagen | Approved | |
| Diclofenac Sodium
ANDA #211253 |
Diclofenac Sodium | Gel; Topical | ORIG-1 | Gage Development | Approved | |
| Docetaxel
ANDA #210327 |
Docetaxel | Injectable; Injection | ORIG-1 | Shilpa Medicare Ltd | Approved | |
| Fragmin
NDA #020287 |
Dalteparin Sodium | Injectable; Injection | SUPPL-72 | Pfizer Inc | Efficacy | Approved |
| Fragmin
NDA #020287 |
Dalteparin Sodium | Injectable; Subcutaneous | SUPPL-72 | Pfizer Inc | Efficacy | Approved |
| Gattex Kit
NDA #203441 |
Teduglutide Recombinant | Powder; Subcutaneous | SUPPL-13 | Nps Pharms Inc | Efficacy | Approved |
| Herzuma
BLA #761091 |
Trastuzumab-Pkrb | Injectable; Injection | SUPPL-1 | Celltrion Inc | Manufacturing (CMC) | Approved |
| Herzuma
BLA #761091 |
Trastuzumab-Pkrb | Injectable; Injection | SUPPL-2 | Celltrion Inc | Efficacy | Approved |
| Jornay Pm
NDA #209311 |
Methylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Ironshore Pharms | Labeling | Approved |
| Livalo
NDA #022363 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-15 | Kowa Co | Efficacy | Approved |
| Nevirapine
ANDA #203411 |
Nevirapine | Tablet, Extended Release; Oral | SUPPL-13 | Sandoz Inc | Efficacy | Approved |
| Rivaroxaban
ANDA #208549 |
Rivaroxaban | Unknown | ORIG-1 | Prinston Inc | Tentative Approval | |
| Testosterone
ANDA #204570 |
Testosterone | Gel, Metered; Transdermal | SUPPL-1 | Actavis Labs Ut Inc | Labeling | Approved |
| Testosterone
ANDA #204570 |
Testosterone | Gel, Metered; Transdermal | SUPPL-1 | Actavis Labs Ut Inc | Labeling | Approved |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-39 | Actelion Pharms Ltd | Labeling | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-5 | Actelion Pharms | Labeling | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-5 | Actelion Pharms | Labeling | Approved |
May 15, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Allopurinol
ANDA #071450 |
Allopurinol | Tablet; Oral | SUPPL-40 | Sun Pharm Industries | Labeling | Approved |
| Antara (Micronized)
NDA #021695 |
Fenofibrate | Capsule; Oral | SUPPL-20 | Lupin Atlantis | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #075753 |
Fenofibrate | Capsule; Oral | SUPPL-10 | Rhodes Pharms | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #075868 |
Fenofibrate | Capsule; Oral | SUPPL-20 | Impax Labs | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #202676 |
Fenofibrate | Capsule; Oral | SUPPL-5 | Mylan Pharms Inc | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #205566 |
Fenofibrate | Capsule; Oral | SUPPL-3 | Glenmark Pharms Ltd | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #207378 |
Fenofibrate | Capsule; Oral | SUPPL-4 | Invagen Pharms | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #207805 |
Fenofibrate | Capsule; Oral | SUPPL-8 | Austarpharma | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #209504 |
Fenofibrate | Capsule; Oral | SUPPL-4 | Amerigen Pharms Ltd | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #210705 |
Fenofibrate | Capsule; Oral | SUPPL-1 | Ajanta Pharma Ltd | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #210782 |
Fenofibrate | Capsule; Oral | SUPPL-1 | Torrent | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #210782 |
Fenofibrate | Capsule; Oral | SUPPL-1 | Torrent | Labeling | Approved |
| Fenoglide
NDA #022118 |
Fenofibrate | Tablet; Oral | SUPPL-10 | Salix | Labeling | Approved |
| Fibricor
NDA #022418 |
Fenofibric Acid | Tablet; Oral | SUPPL-15 | Athena | Labeling | Approved |
| Ibuprofen
ANDA #210149 |
Ibuprofen | Suspension; Oral | SUPPL-1 | Guardian Drug | Manufacturing (CMC) | Approved |
| Lipofen
NDA #021612 |
Fenofibrate | Capsule; Oral | SUPPL-20 | Cipher Pharms Inc | Labeling | Approved |
| Trelegy Ellipta
NDA #209482 |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-5 | Glaxosmithkline | Labeling | Approved |
| Triglide
NDA #021350 |
Fenofibrate | Tablet; Oral | SUPPL-22 | Skyepharma Ag | Labeling | Approved |
| Venclexta
NDA #208573 |
Venetoclax | Tablet; Oral | SUPPL-13 | Abbvie Inc | Efficacy | Approved |
| Zoledronic Acid
ANDA #208513 |
Zoledronic Acid | Injectable; Intravenous | ORIG-1 | Shilpa Medicare Ltd | Approved |
May 14, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albendazole
ANDA #211117 |
Albendazole | Tablet; Oral | ORIG-1 | Edenbridge Pharms | Approved | |
| Bavencio
BLA #761049 |
Avelumab | Injectable; Injection | SUPPL-6 | Emd Serono Inc | Efficacy | Approved |
| Edurant
NDA #202022 |
Rilpivirine Hydrochloride | Tablet; Oral | SUPPL-13 | Janssen Prods | Labeling | Approved |
| Fulvestrant
ANDA #205935 |
Fulvestrant | Injectable; Intramuscular | ORIG-1 | Sandoz Inc | Approved | |
| Gemzar
NDA #020509 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-82 | Lilly | Labeling | Approved |
| Glycopyrrolate
ANDA #211334 |
Glycopyrrolate | Injectable; Injection | ORIG-1 | Sandoz Inc | Approved | |
| Vasostrict
NDA #204485 |
Vasopressin | Solution; Intravenous | SUPPL-9 | Par Sterile Products | Labeling | Approved |
May 13, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-63 | Bayer | Labeling | Approved |
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-64 | Bayer | Labeling | Approved |
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-65 | Bayer | Labeling | Approved |
| Corlanor
NDA #206143 |
Ivabradine Hydrochloride | Tablet; Oral | SUPPL-7 | Amgen Inc | Labeling | Approved |
| Corlanor
NDA #206143 |
Ivabradine Hydrochloride | Tablet; Oral | SUPPL-7 | Amgen Inc | Labeling | Approved |
| Doxorubicin Hydrochloride
ANDA #206062 |
Doxorubicin Hydrochloride | Injectable; Injection | ORIG-1 | Hisun Pharm Hangzhou | Approved | |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-7 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #202122 |
Entecavir | Tablet; Oral | SUPPL-7 | Teva Pharms Usa | Labeling | Approved |
| Entecavir
ANDA #206872 |
Entecavir | Tablet; Oral | SUPPL-2 | Cipla | Labeling | Approved |
| Entecavir
ANDA #206872 |
Entecavir | Tablet; Oral | SUPPL-3 | Cipla | Labeling | Approved |
| Entecavir
ANDA #206872 |
Entecavir | Tablet; Oral | SUPPL-3 | Cipla | Labeling | Approved |
| Entecavir
ANDA #208721 |
Entecavir | Tablet; Oral | SUPPL-1 | Breckenridge Pharm | Labeling | Approved |
| Eylea
BLA #125387 |
Aflibercept | Injectable; Injection | SUPPL-61 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Fenofibrate (Micronized)
ANDA #209504 |
Fenofibrate | Capsule; Oral | SUPPL-2 | Amerigen Pharms Ltd | Labeling | Approved |
| Labetalol Hydrochloride
ANDA #211325 |
Labetalol Hydrochloride | Tablet; Oral | ORIG-1 | Cadila Pharms Ltd | Approved | |
| Neostigmine Methylsulfate
ANDA #212512 |
Neostigmine Methylsulfate | Solution; Intravenous | ORIG-1 | Be Pharms | Approved | |
| Odomzo
NDA #205266 |
Sonidegib Phosphate | Capsule; Oral | SUPPL-6 | Sun Pharma Global | Labeling | Approved |
| Risedronate Sodium
ANDA #205280 |
Risedronate Sodium | Tablet; Oral | ORIG-1 | Orchid Hlthcare | Approved |
May 10, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Anafranil
NDA #019906 |
Clomipramine Hydrochloride | Capsule; Oral | SUPPL-43 | Specgx Llc | Labeling | Approved |
| Androgel
NDA #021015 |
Testosterone | Gel, Metered; Transdermal | SUPPL-45 | Abbvie | Labeling | Approved |
| Androgel
NDA #021015 |
Testosterone | Gel; Transdermal | SUPPL-45 | Abbvie | Labeling | Approved |
| Androgel
NDA #022309 |
Testosterone | Gel, Metered; Transdermal | SUPPL-20 | Abbvie | Labeling | Approved |
| Androgel
NDA #022309 |
Testosterone | Gel; Transdermal | SUPPL-20 | Abbvie | Labeling | Approved |
| Caduet
NDA #021540 |
Amlodipine Besylate; Atorvastatin Calcium | Tablet; Oral | SUPPL-44 | Pfizer | Labeling | Approved |
| Chlorthalidone
ANDA #207813 |
Chlorthalidone | Tablet; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Combivir
NDA #020857 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-34 | Viiv Hlthcare | Labeling | Approved |
| Cyramza
BLA #125477 |
Ramucirumab | Injectable; Injection | SUPPL-29 | Eli Lilly and Co | Efficacy | Approved |
| Dexamethasone Sodium Phosphate
ANDA #211036 |
Dexamethasone Sodium Phosphate | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Epivir
NDA #020564 |
Lamivudine | Tablet; Oral | SUPPL-39 | Viiv Hlthcare | Labeling | Approved |
| Epivir
NDA #020564 |
Lamivudine | Tablet; Oral | SUPPL-39 | Viiv Hlthcare | Labeling | Approved |
| Epivir
NDA #020596 |
Lamivudine | Solution; Oral | SUPPL-38 | Viiv Hlthcare | Labeling | Approved |
| Epivir
NDA #020596 |
Lamivudine | Solution; Oral | SUPPL-38 | Viiv Hlthcare | Labeling | Approved |
| Epzicom
NDA #021652 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | SUPPL-24 | Viiv Hlthcare | Labeling | Approved |
| Epzicom
NDA #021652 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | SUPPL-24 | Viiv Hlthcare | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209495 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | ORIG-1 | Glenmark Pharms | Approved | |
| Fortesta
NDA #021463 |
Testosterone | Gel, Metered; Transdermal | SUPPL-20 | Endo Pharms | Labeling | Approved |
| Fortesta
NDA #021463 |
Testosterone | Gel, Metered; Transdermal | SUPPL-20 | Endo Pharms | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-13 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-16 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-12 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-13 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-14 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #091269 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-16 | Dr Reddys Labs Ltd | Labeling | Approved |
| Lansoprazole
ANDA #202176 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-8 | Wockhardt Usa | Labeling | Approved |
| Lansoprazole
ANDA #202176 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-7 | Wockhardt Usa | Labeling | Approved |
| Lansoprazole
ANDA #202176 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-8 | Wockhardt Usa | Labeling | Approved |
| Naproxen Sodium and Diphenhydramine Hydrochloride
ANDA #208499 |
Diphenhydramine Hydrochloride; Naproxen Sodium | Tablet; Oral | ORIG-1 | Perrigo R and D | Approved | |
| Nuplazid
NDA #207318 |
Pimavanserin Tartrate | Tablet; Oral | SUPPL-7 | Acadia Pharms Inc | Labeling | Approved |
| Nuplazid
NDA #210793 |
Pimavanserin Tartrate | Capsule; Oral | SUPPL-2 | Acadia Pharms Inc | Labeling | Approved |
| Oxybutynin Chloride
ANDA #211682 |
Oxybutynin Chloride | Tablet; Oral | ORIG-1 | Emcure Pharms Ltd | Approved | |
| Sapropterin Dihydrochloride
ANDA #207200 |
Sapropterin Dihydrochloride | Tablet; Oral | ORIG-1 | Par Pharm Inc | Approved | |
| Testim
NDA #021454 |
Testosterone | Gel; Transdermal | SUPPL-27 | Auxilium Pharms Llc | Labeling | Approved |
| Testim
NDA #021454 |
Testosterone | Gel; Transdermal | SUPPL-27 | Auxilium Pharms Llc | Labeling | Approved |
| Testosterone
ANDA #204255 |
Testosterone | Solution, Metered; Transdermal | SUPPL-4 | Perrigo Israel | Labeling | Approved |
| Testosterone
ANDA #204255 |
Testosterone | Solution, Metered; Transdermal | SUPPL-4 | Perrigo Israel | Labeling | Approved |
| Testosterone
ANDA #205328 |
Testosterone | Solution, Metered; Transdermal | SUPPL-1 | Actavis Labs Ut Inc | Labeling | Approved |
| Testosterone
ANDA #205328 |
Testosterone | Solution, Metered; Transdermal | SUPPL-1 | Actavis Labs Ut Inc | Labeling | Approved |
| Testosterone
ANDA #208061 |
Testosterone | Solution, Metered; Transdermal | SUPPL-1 | Lupin Ltd | Labeling | Approved |
| Testosterone
ANDA #208061 |
Testosterone | Solution, Metered; Transdermal | SUPPL-1 | Lupin Ltd | Labeling | Approved |
| Testosterone
ANDA #209533 |
Testosterone | Solution, Metered; Transdermal | SUPPL-3 | Cipla | Labeling | Approved |
| Trizivir
NDA #021205 |
Abacavir Sulfate; Lamivudine; Zidovudine | Tablet; Oral | SUPPL-38 | Viiv Hlthcare | Labeling | Approved |
| Trizivir
NDA #021205 |
Abacavir Sulfate; Lamivudine; Zidovudine | Tablet; Oral | SUPPL-38 | Viiv Hlthcare | Labeling | Approved |
| Vogelxo
NDA #204399 |
Testosterone | Gel, Metered; Transdermal | SUPPL-10 | Upsher Smith Labs | Labeling | Approved |
| Vogelxo
NDA #204399 |
Testosterone | Gel; Transdermal | SUPPL-10 | Upsher Smith Labs | Labeling | Approved |
| Xeomin
BLA #125360 |
Incobotulinumtoxina | Injectable; Injection | SUPPL-74 | Merz Pharms | Efficacy | Approved |
| Zosyn
NDA #050684 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | SUPPL-94 | Wyeth Pharms | Labeling | Approved |
| Zosyn In Plastic Container
NDA #050750 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | SUPPL-41 | Wyeth Pharms | Labeling | Approved |
May 9, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Armodafinil
ANDA #200043 |
Armodafinil | Tablet; Oral | ORIG-2 | Mylan Pharms Inc | Approved | |
| Creon
NDA #020725 |
Pancrelipase (Amylase;Lipase;Protease) | Capsule, Delayed Release; Oral | SUPPL-25 | Abbvie | Labeling | Approved |
| Hydroxyprogesterone Caproate
ANDA #211142 |
Hydroxyprogesterone Caproate | Solution; Intramuscular | ORIG-1 | Eugia Pharma | Approved | |
| Lacosamide
ANDA #209301 |
Lacosamide | Unknown | ORIG-1 | Hetero Labs Unit Iii | Tentative Approval | |
| Lantus
NDA #021081 |
Insulin Glargine Recombinant | Injectable; Injection | SUPPL-72 | Sanofi Aventis Us | Labeling | Approved |
| Lantus Solostar
NDA #021081 |
Insulin Glargine Recombinant | Injectable; Injection | SUPPL-72 | Sanofi Aventis Us | Labeling | Approved |
| Mesalamine
ANDA #207873 |
Mesalamine | Capsule, Delayed Release; Oral | ORIG-1 | Teva Pharms Usa | Approved | |
| Spravato
NDA #211243 |
Esketamine | Spray; Nasal | SUPPL-1 | Janssen Pharms | Labeling | Approved |
| Spravato
NDA #211243 |
Esketamine Hydrochloride | Spray; Nasal | SUPPL-1 | Janssen Pharms | Labeling | Approved |
May 8, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bethanechol Chloride
ANDA #040725 |
Bethanechol Chloride | Tablet; Oral | SUPPL-2 | Eci Pharms Llc | Manufacturing (CMC) | Approved |
| Bethanechol Chloride
ANDA #040726 |
Bethanechol Chloride | Tablet; Oral | SUPPL-2 | Eci Pharms Llc | Manufacturing (CMC) | Approved |
| Bethanechol Chloride
ANDA #040727 |
Bethanechol Chloride | Tablet; Oral | SUPPL-2 | Eci Pharms Llc | Manufacturing (CMC) | Approved |
| Bethanechol Chloride
ANDA #040728 |
Bethanechol Chloride | Tablet; Oral | SUPPL-2 | Eci Pharms Llc | Manufacturing (CMC) | Approved |
| Busulfan
ANDA #207050 |
Busulfan | Injectable; Injection | SUPPL-1 | Pharmascience Inc | Labeling | Approved |
| Busulfan
ANDA #207050 |
Busulfan | Injectable; Injection | SUPPL-2 | Pharmascience Inc | Labeling | Approved |
| Dapsone
ANDA #207165 |
Dapsone | Tablet; Oral | ORIG-1 | Sai Life Sciences | Approved | |
| Decadron
NDA #011664 |
Dexamethasone | Tablet; Oral | SUPPL-64 | Merck | Labeling | Approved |
| Eszopiclone
ANDA #203087 |
Eszopiclone | Tablet; Oral | ORIG-1 | Breckenridge Pharm | Approved | |
| Lo/Ovral-28
NDA #017802 |
Ethinyl Estradiol; Norgestrel | Tablet; Oral-28 | SUPPL-34 | Wyeth Pharms | Labeling | Approved |
| Norminest Fe
NDA #017948 |
Ethinyl Estradiol;Norethindrone; Ferrous Fumarate | Tablet; Oral | SUPPL-46 | Gd Searle Llc | Labeling | Approved |
| Norquest Fe
NDA #018926 |
Ethinyl Estradiol; Ferrous Fumarate; Norethindrone | Tablet; Oral-28 | SUPPL-13 | Gd Searle Llc | Labeling | Approved |
| Nuvaring
NDA #021187 |
Ethinyl Estradiol; Etonogestrel | Ring; Vaginal | SUPPL-37 | Organon Sub Merck | Labeling | Approved |
| Omnaris
NDA #022004 |
Ciclesonide | Spray, Metered; Nasal | SUPPL-18 | Covis Pharma Bv | Labeling | Approved |
| Prolia
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-196 | Amgen | Labeling | Approved |
| Prolia
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-199 | Amgen | Labeling | Approved |
| Triphasil-21
NDA #019192 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-21 | SUPPL-48 | Wyeth Pharms | Labeling | Approved |
| Triphasil-28
NDA #019190 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-49 | Wyeth Pharms Inc | Labeling | Approved |
| Xgeva
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-196 | Amgen | Labeling | Approved |
| Xgeva
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-199 | Amgen | Labeling | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-102 | Bristol Myers Squibb | Labeling | Approved |
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