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.
July 22, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Anaprox
NDA #018164 |
Naproxen Sodium | Tablet; Oral | SUPPL-64 | Atnahs Pharma Us | Labeling | Approved |
| Anaprox Ds
NDA #018164 |
Naproxen Sodium | Tablet; Oral | SUPPL-64 | Atnahs Pharma Us | Labeling | Approved |
| Caldolor
NDA #022348 |
Ibuprofen | Solution; Intravenous | SUPPL-14 | Cumberland Pharms | Labeling | Approved |
| Droxia
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-51 | Bristol Myers Squibb | Labeling | Approved |
| Duexis
NDA #022519 |
Famotidine; Ibuprofen | Tablet; Oral | SUPPL-12 | Horizon | Labeling | Approved |
| Ec-Naprosyn
NDA #020067 |
Naproxen | Tablet, Delayed Release; Oral | SUPPL-21 | Atnahs Pharma Us | Labeling | Approved |
| Hydrea
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-51 | Bristol Myers Squibb | Labeling | Approved |
| Metformin Hydrochloride
ANDA #202917 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-7 | Sun Pharm | Manufacturing (CMC) | Approved |
| Morphine Sulfate
ANDA #210610 |
Morphine Sulfate | Tablet; Oral | ORIG-1 | Upsher Smith Labs | Approved | |
| Naprelan
NDA #020353 |
Naproxen Sodium | Tablet, Extended Release; Oral | SUPPL-36 | Alvogen | Labeling | Approved |
| Naprelan
NDA #020353 |
Naproxen Sodium | Tablet, Extended Release; Oral | SUPPL-36 | Alvogen | Labeling | Approved |
| Naprelan
NDA #020353 |
Naproxen Sodium | Tablet, Extended Release; Oral | SUPPL-36 | Alvogen | Labeling | Approved |
| Naprosyn
NDA #017581 |
Naproxen | Tablet; Oral | SUPPL-114 | Atnahs Pharma Us | Labeling | Approved |
| Naprosyn
NDA #018965 |
Naproxen | Suspension; Oral | SUPPL-26 | Atnahs Pharma Us | Labeling | Approved |
| Ramelteon
ANDA #211567 |
Ramelteon | Tablet; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Serevent
NDA #020692 |
Salmeterol Xinafoate | Powder; Inhalation | SUPPL-47 | Glaxosmithkline | Labeling | Approved |
| Vimovo
NDA #022511 |
Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release; Oral | SUPPL-24 | Horizon | Labeling | Approved |
July 21, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-15 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-16 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-18 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-19 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-20 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-1 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-3 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-6 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-2 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-3 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-4 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-5 | Gland Pharma Ltd | Labeling | Approved |
July 19, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apremilast
ANDA #211782 |
Apremilast | Unknown | ORIG-1 | Amneal Pharms Co | Tentative Approval | |
| Clobazam
ANDA #211259 |
Clobazam | Suspension; Oral | SUPPL-1 | Mylan | Manufacturing (CMC) | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-7 | Accord Hlthcare | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-9 | Accord Hlthcare | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Copaxone
NDA #020622 |
Glatiramer Acetate | For Solution; Subcutaneous | SUPPL-106 | Teva Pharms Usa | Labeling | Approved |
| Copaxone
NDA #020622 |
Glatiramer Acetate | Injectable; Subcutaneous | SUPPL-106 | Teva Pharms Usa | Labeling | Approved |
| Dapagliflozin
ANDA #211560 |
Dapagliflozin | Unknown | ORIG-1 | Alembic Pharms Ltd | Tentative Approval | |
| Dexmethylphenidate Hydrochloride
ANDA #212631 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Drizalma Sprinkle
NDA #212516 |
Duloxetine | Capsule, Delayed Release; Oral | ORIG-1 | Sun Pharma Global | Type 5 - New Formulation or New Manufacturer | Approved |
| Erlotinib
ANDA #210300 |
Erlotinib | Unknown | ORIG-1 | Sun Pharm Industries | Tentative Approval | |
| Imfinzi
BLA #761069 |
Durvalumab | Injectable; Injection | SUPPL-13 | Astrazeneca Uk Ltd | Efficacy | Approved |
| Otezla
NDA #205437 |
Apremilast | Tablet; Oral | SUPPL-7 | Celgene Corp | Efficacy | Approved |
| Pregabalin
ANDA #203459 |
Pregabalin | Capsule; Oral | ORIG-1 | Alembic Pharms Ltd | Approved | |
| Pregabalin
ANDA #207623 |
Pregabalin | Solution; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Pregabalin
ANDA #207799 |
Pregabalin | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Pregabalin
ANDA #208677 |
Pregabalin | Capsule; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Pregabalin
ANDA #209357 |
Pregabalin | Capsule; Oral | ORIG-1 | Msn Labs Pvt Ltd | Approved | |
| Pregabalin
ANDA #209664 |
Pregabalin | Capsule; Oral | ORIG-1 | Dr Reddys | Approved | |
| Pregabalin
ANDA #209743 |
Pregabalin | Capsule; Oral | ORIG-1 | Amneal Pharms Co | Approved | |
| Pregabalin
ANDA #210432 |
Pregabalin | Capsule; Oral | ORIG-1 | Rising | Approved | |
| Pregabalin
ANDA #211384 |
Pregabalin | Capsule; Oral | ORIG-1 | Invagen Pharms | Approved | |
| Zyban
NDA #020711 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-48 | Glaxosmithkline | Labeling | Approved |
July 18, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bevyxxa
NDA #208383 |
Betrixaban | Capsule; Oral | SUPPL-6 | Portola Pharms Inc | Labeling | Approved |
| Fenofibric Acid
ANDA #211626 |
Choline Fenofibrate | Capsule, Delayed Release; Oral | ORIG-1 | Graviti Pharms | Approved | |
| Lamisil At
NDA #021124 |
Terbinafine Hydrochloride | Solution; Topical | SUPPL-15 | Glaxosmithkline Cons | Manufacturing (CMC) | Approved |
| Lamisil At
NDA #021124 |
Terbinafine Hydrochloride | Spray; Topical | SUPPL-15 | Glaxosmithkline Cons | Manufacturing (CMC) | Approved |
| Lialda
NDA #022000 |
Mesalamine | Tablet, Delayed Release; Oral | SUPPL-18 | Shire | Labeling | Approved |
| Megace
NDA #020264 |
Megestrol Acetate | Suspension; Oral | SUPPL-21 | Bristol Myers Squibb | Labeling | Approved |
| Mepron
NDA #020500 |
Atovaquone | Suspension; Oral | SUPPL-19 | Glaxosmithkline Llc | Labeling | Approved |
| Olmesartan Medoxomil
ANDA #207135 |
Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Umedica Labs Pvt Ltd | Approved | |
| Prostin Vr Pediatric
NDA #018484 |
Alprostadil | Injectable; Injection | SUPPL-28 | Pharmacia and Upjohn | Labeling | Approved |
| Zinc Sulfate
NDA #209377 |
Zinc Sulfate | Injectable; Injection | ORIG-1 | American Regent Inc | Type 5 - New Formulation or New Manufacturer | Approved |
July 17, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Dapagliflozin
ANDA #211312 |
Dapagliflozin | Unknown | ORIG-1 | Sandoz Inc | Tentative Approval | |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #210080 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | ORIG-1 | Nesher Pharms | Approved | |
| Lamisil
NDA #020980 |
Terbinafine Hydrochloride | Cream; Topical | SUPPL-12 | Glaxosmithkline | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #091072 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-8 | Apotex Inc | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #091072 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-7 | Apotex Inc | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #091072 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-8 | Apotex Inc | Labeling | Approved |
| Tranexamic Acid
ANDA #212360 |
Tranexamic Acid | Injectable; Injection | ORIG-1 | Caplin | Approved | |
| Tranexamic Acid
ANDA #212676 |
Tranexamic Acid | Injectable; Injection | ORIG-1 | Apollo Pharms Inc | Approved |
July 16, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Dactinomycin
ANDA #207232 |
Dactinomycin | Injectable; Injection | ORIG-1 | Hisun Pharm Hangzhou | Approved | |
| Darzalex
BLA #761036 |
Daratumumab | Injectable; Injection | SUPPL-19 | Janssen Biotech | Labeling | Approved |
| Enzalutamide
ANDA #211465 |
Enzalutamide | Unknown | ORIG-1 | Eugia Pharma | Tentative Approval | |
| Everolimus
ANDA #207486 |
Everolimus | Tablet; Oral | ORIG-1 | West-Ward Pharms Int | Tentative Approval | |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-13 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-14 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-15 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-16 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-13 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-14 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-15 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-16 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-14 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-15 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-14 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-15 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-2 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-2 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Gefitinib
ANDA #211826 |
Gefitinib | Unknown | ORIG-1 | Cipla Ltd | Tentative Approval | |
| Lamivudine and Zidovudine
ANDA #079128 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-13 | Strides Pharma | Labeling | Approved |
| Lamivudine and Zidovudine
ANDA #079128 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
| Linezolid
ANDA #204764 |
Linezolid | Solution; Intravenous | SUPPL-3 | Fresenius Kabi Usa | Labeling | Approved |
| Mekinist
NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-13 | Novartis Pharms Corp | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-19 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-19 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-21 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-19 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-21 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-22 | Thepharmanetwork Llc | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #070184 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-69 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #070184 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-69 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #071250 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-37 | Impax Labs Inc | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #072801 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-44 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #072801 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-44 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #077878 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-12 | Vintage Pharms | Labeling | Approved |
| Mupirocin
ANDA #201587 |
Mupirocin Calcium | Cream; Topical | SUPPL-9 | Glenmark Pharms Inc | Labeling | Approved |
| Ocrevus
BLA #761053 |
Ocrelizumab | Injectable; Injection | SUPPL-18 | Genentech Inc | Labeling | Approved |
| Pentasa
NDA #020049 |
Mesalamine | Capsule, Extended Release; Oral | SUPPL-32 | Shire | Labeling | Approved |
| Recarbrio
NDA #212819 |
Imipenem;Cilastatin;Relebactam | Injectable; Intravenous | ORIG-1 | Merck Sharp Dohme | Type 1 - New Molecular Entity and Type 4 - New Combination | Approved |
| Rivastigmine Tartrate
ANDA #077130 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-5 | Dr Reddys Labs Inc | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #077130 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-6 | Dr Reddys Labs Inc | Labeling | Approved |
| Tafinlar
NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-13 | Novartis Pharms Corp | Labeling | Approved |
| Temozolomide
ANDA #203691 |
Temozolomide | Capsule; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Temozolomide
ANDA #203691 |
Temozolomide | Capsule; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
July 15, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Austedo
NDA #208082 |
Deutetrabenazine | Tablet; Oral | SUPPL-4 | Teva Branded Pharm | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.075% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.15% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.224% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.3% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Heparin Sodium 1,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609 |
Heparin Sodium | Injectable; Injection | SUPPL-54 | Baxter Hlthcare | Labeling | Approved |
| Heparin Sodium 2,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609 |
Heparin Sodium | Injectable; Injection | SUPPL-54 | Baxter Hlthcare | Labeling | Approved |
| Heparin Sodium 5,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609 |
Heparin Sodium | Injectable; Injection | SUPPL-54 | Baxter Hlthcare | Labeling | Approved |
| Icatibant Acetate
ANDA #210118 |
Icatibant Acetate | Injectable; Subcutaneous | ORIG-1 | Teva Pharms Usa | Approved | |
| Imbruvica
NDA #205552 |
Ibrutinib | Capsule; Oral | SUPPL-28 | Pharmacyclics Inc | Labeling | Approved |
| Imbruvica
NDA #210563 |
Ibrutinib | Tablet; Oral | SUPPL-3 | Pharmacyclics Inc | Labeling | Approved |
| Ingrezza
NDA #209241 |
Valbenazine Tosylate | Capsule; Oral | SUPPL-12 | Neurocrine | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #204659 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Par Pharm | Approved | |
| Rapamune
NDA #021083 |
Sirolimus | Solution; Oral | SUPPL-64 | Pf Prism Cv | Labeling | Approved |
| Rapamune
NDA #021110 |
Sirolimus | Tablet; Oral | SUPPL-83 | Pf Prism Cv | Labeling | Approved |
July 22, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Anaprox
NDA #018164 |
Naproxen Sodium | Tablet; Oral | SUPPL-64 | Atnahs Pharma Us | Labeling | Approved |
| Anaprox Ds
NDA #018164 |
Naproxen Sodium | Tablet; Oral | SUPPL-64 | Atnahs Pharma Us | Labeling | Approved |
| Caldolor
NDA #022348 |
Ibuprofen | Solution; Intravenous | SUPPL-14 | Cumberland Pharms | Labeling | Approved |
| Droxia
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-51 | Bristol Myers Squibb | Labeling | Approved |
| Duexis
NDA #022519 |
Famotidine; Ibuprofen | Tablet; Oral | SUPPL-12 | Horizon | Labeling | Approved |
| Ec-Naprosyn
NDA #020067 |
Naproxen | Tablet, Delayed Release; Oral | SUPPL-21 | Atnahs Pharma Us | Labeling | Approved |
| Hydrea
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-51 | Bristol Myers Squibb | Labeling | Approved |
| Metformin Hydrochloride
ANDA #202917 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-7 | Sun Pharm | Manufacturing (CMC) | Approved |
| Morphine Sulfate
ANDA #210610 |
Morphine Sulfate | Tablet; Oral | ORIG-1 | Upsher Smith Labs | Approved | |
| Naprelan
NDA #020353 |
Naproxen Sodium | Tablet, Extended Release; Oral | SUPPL-36 | Alvogen | Labeling | Approved |
| Naprelan
NDA #020353 |
Naproxen Sodium | Tablet, Extended Release; Oral | SUPPL-36 | Alvogen | Labeling | Approved |
| Naprelan
NDA #020353 |
Naproxen Sodium | Tablet, Extended Release; Oral | SUPPL-36 | Alvogen | Labeling | Approved |
| Naprosyn
NDA #017581 |
Naproxen | Tablet; Oral | SUPPL-114 | Atnahs Pharma Us | Labeling | Approved |
| Naprosyn
NDA #018965 |
Naproxen | Suspension; Oral | SUPPL-26 | Atnahs Pharma Us | Labeling | Approved |
| Ramelteon
ANDA #211567 |
Ramelteon | Tablet; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Serevent
NDA #020692 |
Salmeterol Xinafoate | Powder; Inhalation | SUPPL-47 | Glaxosmithkline | Labeling | Approved |
| Vimovo
NDA #022511 |
Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release; Oral | SUPPL-24 | Horizon | Labeling | Approved |
July 21, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-15 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-16 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-18 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-19 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #091404 |
Meropenem | Injectable; Injection | SUPPL-20 | Acs Dobfar | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-1 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-3 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #205883 |
Meropenem | Injectable; Injection | SUPPL-6 | Amneal Pharms | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-2 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-3 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-4 | Gland Pharma Ltd | Labeling | Approved |
| Meropenem
ANDA #206141 |
Meropenem | Injectable; Injection | SUPPL-5 | Gland Pharma Ltd | Labeling | Approved |
July 19, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apremilast
ANDA #211782 |
Apremilast | Unknown | ORIG-1 | Amneal Pharms Co | Tentative Approval | |
| Clobazam
ANDA #211259 |
Clobazam | Suspension; Oral | SUPPL-1 | Mylan | Manufacturing (CMC) | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-7 | Accord Hlthcare | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-9 | Accord Hlthcare | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202925 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Copaxone
NDA #020622 |
Glatiramer Acetate | For Solution; Subcutaneous | SUPPL-106 | Teva Pharms Usa | Labeling | Approved |
| Copaxone
NDA #020622 |
Glatiramer Acetate | Injectable; Subcutaneous | SUPPL-106 | Teva Pharms Usa | Labeling | Approved |
| Dapagliflozin
ANDA #211560 |
Dapagliflozin | Unknown | ORIG-1 | Alembic Pharms Ltd | Tentative Approval | |
| Dexmethylphenidate Hydrochloride
ANDA #212631 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Drizalma Sprinkle
NDA #212516 |
Duloxetine | Capsule, Delayed Release; Oral | ORIG-1 | Sun Pharma Global | Type 5 - New Formulation or New Manufacturer | Approved |
| Erlotinib
ANDA #210300 |
Erlotinib | Unknown | ORIG-1 | Sun Pharm Industries | Tentative Approval | |
| Imfinzi
BLA #761069 |
Durvalumab | Injectable; Injection | SUPPL-13 | Astrazeneca Uk Ltd | Efficacy | Approved |
| Otezla
NDA #205437 |
Apremilast | Tablet; Oral | SUPPL-7 | Celgene Corp | Efficacy | Approved |
| Pregabalin
ANDA #203459 |
Pregabalin | Capsule; Oral | ORIG-1 | Alembic Pharms Ltd | Approved | |
| Pregabalin
ANDA #207623 |
Pregabalin | Solution; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Pregabalin
ANDA #207799 |
Pregabalin | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Pregabalin
ANDA #208677 |
Pregabalin | Capsule; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Pregabalin
ANDA #209357 |
Pregabalin | Capsule; Oral | ORIG-1 | Msn Labs Pvt Ltd | Approved | |
| Pregabalin
ANDA #209664 |
Pregabalin | Capsule; Oral | ORIG-1 | Dr Reddys | Approved | |
| Pregabalin
ANDA #209743 |
Pregabalin | Capsule; Oral | ORIG-1 | Amneal Pharms Co | Approved | |
| Pregabalin
ANDA #210432 |
Pregabalin | Capsule; Oral | ORIG-1 | Rising | Approved | |
| Pregabalin
ANDA #211384 |
Pregabalin | Capsule; Oral | ORIG-1 | Invagen Pharms | Approved | |
| Zyban
NDA #020711 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-48 | Glaxosmithkline | Labeling | Approved |
July 18, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bevyxxa
NDA #208383 |
Betrixaban | Capsule; Oral | SUPPL-6 | Portola Pharms Inc | Labeling | Approved |
| Fenofibric Acid
ANDA #211626 |
Choline Fenofibrate | Capsule, Delayed Release; Oral | ORIG-1 | Graviti Pharms | Approved | |
| Lamisil At
NDA #021124 |
Terbinafine Hydrochloride | Solution; Topical | SUPPL-15 | Glaxosmithkline Cons | Manufacturing (CMC) | Approved |
| Lamisil At
NDA #021124 |
Terbinafine Hydrochloride | Spray; Topical | SUPPL-15 | Glaxosmithkline Cons | Manufacturing (CMC) | Approved |
| Lialda
NDA #022000 |
Mesalamine | Tablet, Delayed Release; Oral | SUPPL-18 | Shire | Labeling | Approved |
| Megace
NDA #020264 |
Megestrol Acetate | Suspension; Oral | SUPPL-21 | Bristol Myers Squibb | Labeling | Approved |
| Mepron
NDA #020500 |
Atovaquone | Suspension; Oral | SUPPL-19 | Glaxosmithkline Llc | Labeling | Approved |
| Olmesartan Medoxomil
ANDA #207135 |
Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Umedica Labs Pvt Ltd | Approved | |
| Prostin Vr Pediatric
NDA #018484 |
Alprostadil | Injectable; Injection | SUPPL-28 | Pharmacia and Upjohn | Labeling | Approved |
| Zinc Sulfate
NDA #209377 |
Zinc Sulfate | Injectable; Injection | ORIG-1 | American Regent Inc | Type 5 - New Formulation or New Manufacturer | Approved |
July 17, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Dapagliflozin
ANDA #211312 |
Dapagliflozin | Unknown | ORIG-1 | Sandoz Inc | Tentative Approval | |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #210080 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | ORIG-1 | Nesher Pharms | Approved | |
| Lamisil
NDA #020980 |
Terbinafine Hydrochloride | Cream; Topical | SUPPL-12 | Glaxosmithkline | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #091072 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-8 | Apotex Inc | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #091072 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-7 | Apotex Inc | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #091072 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-8 | Apotex Inc | Labeling | Approved |
| Tranexamic Acid
ANDA #212360 |
Tranexamic Acid | Injectable; Injection | ORIG-1 | Caplin | Approved | |
| Tranexamic Acid
ANDA #212676 |
Tranexamic Acid | Injectable; Injection | ORIG-1 | Apollo Pharms Inc | Approved |
July 16, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Dactinomycin
ANDA #207232 |
Dactinomycin | Injectable; Injection | ORIG-1 | Hisun Pharm Hangzhou | Approved | |
| Darzalex
BLA #761036 |
Daratumumab | Injectable; Injection | SUPPL-19 | Janssen Biotech | Labeling | Approved |
| Enzalutamide
ANDA #211465 |
Enzalutamide | Unknown | ORIG-1 | Eugia Pharma | Tentative Approval | |
| Everolimus
ANDA #207486 |
Everolimus | Tablet; Oral | ORIG-1 | West-Ward Pharms Int | Tentative Approval | |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-13 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-14 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-15 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-16 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-13 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-14 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-15 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076077 |
Fluconazole | Tablet; Oral | SUPPL-16 | Ivax Sub Teva Pharms | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-14 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-15 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-14 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-15 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #076658 |
Fluconazole | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Inc | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-2 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-2 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Fluconazole
ANDA #208963 |
Fluconazole | Tablet; Oral | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Gefitinib
ANDA #211826 |
Gefitinib | Unknown | ORIG-1 | Cipla Ltd | Tentative Approval | |
| Lamivudine and Zidovudine
ANDA #079128 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-13 | Strides Pharma | Labeling | Approved |
| Lamivudine and Zidovudine
ANDA #079128 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
| Linezolid
ANDA #204764 |
Linezolid | Solution; Intravenous | SUPPL-3 | Fresenius Kabi Usa | Labeling | Approved |
| Mekinist
NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-13 | Novartis Pharms Corp | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-19 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-19 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-21 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-19 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-21 | Thepharmanetwork Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-22 | Thepharmanetwork Llc | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #070184 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-69 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #070184 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-69 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #071250 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-37 | Impax Labs Inc | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #072801 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-44 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #072801 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-44 | Teva | Labeling | Approved |
| Metoclopramide Hydrochloride
ANDA #077878 |
Metoclopramide Hydrochloride | Tablet; Oral | SUPPL-12 | Vintage Pharms | Labeling | Approved |
| Mupirocin
ANDA #201587 |
Mupirocin Calcium | Cream; Topical | SUPPL-9 | Glenmark Pharms Inc | Labeling | Approved |
| Ocrevus
BLA #761053 |
Ocrelizumab | Injectable; Injection | SUPPL-18 | Genentech Inc | Labeling | Approved |
| Pentasa
NDA #020049 |
Mesalamine | Capsule, Extended Release; Oral | SUPPL-32 | Shire | Labeling | Approved |
| Recarbrio
NDA #212819 |
Imipenem;Cilastatin;Relebactam | Injectable; Intravenous | ORIG-1 | Merck Sharp Dohme | Type 1 - New Molecular Entity and Type 4 - New Combination | Approved |
| Rivastigmine Tartrate
ANDA #077130 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-5 | Dr Reddys Labs Inc | Labeling | Approved |
| Rivastigmine Tartrate
ANDA #077130 |
Rivastigmine Tartrate | Capsule; Oral | SUPPL-6 | Dr Reddys Labs Inc | Labeling | Approved |
| Tafinlar
NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-13 | Novartis Pharms Corp | Labeling | Approved |
| Temozolomide
ANDA #203691 |
Temozolomide | Capsule; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Temozolomide
ANDA #203691 |
Temozolomide | Capsule; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
July 15, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Austedo
NDA #208082 |
Deutetrabenazine | Tablet; Oral | SUPPL-4 | Teva Branded Pharm | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.075% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.15% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.224% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Dextrose 5% and Potassium Chloride 0.3% In Plastic Container
NDA #017634 |
Dextrose; Potassium Chloride | Injectable; Injection | SUPPL-76 | Baxter Hlthcare | Labeling | Approved |
| Heparin Sodium 1,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609 |
Heparin Sodium | Injectable; Injection | SUPPL-54 | Baxter Hlthcare | Labeling | Approved |
| Heparin Sodium 2,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609 |
Heparin Sodium | Injectable; Injection | SUPPL-54 | Baxter Hlthcare | Labeling | Approved |
| Heparin Sodium 5,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609 |
Heparin Sodium | Injectable; Injection | SUPPL-54 | Baxter Hlthcare | Labeling | Approved |
| Icatibant Acetate
ANDA #210118 |
Icatibant Acetate | Injectable; Subcutaneous | ORIG-1 | Teva Pharms Usa | Approved | |
| Imbruvica
NDA #205552 |
Ibrutinib | Capsule; Oral | SUPPL-28 | Pharmacyclics Inc | Labeling | Approved |
| Imbruvica
NDA #210563 |
Ibrutinib | Tablet; Oral | SUPPL-3 | Pharmacyclics Inc | Labeling | Approved |
| Ingrezza
NDA #209241 |
Valbenazine Tosylate | Capsule; Oral | SUPPL-12 | Neurocrine | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #204659 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Par Pharm | Approved | |
| Rapamune
NDA #021083 |
Sirolimus | Solution; Oral | SUPPL-64 | Pf Prism Cv | Labeling | Approved |
| Rapamune
NDA #021110 |
Sirolimus | Tablet; Oral | SUPPL-83 | Pf Prism Cv | Labeling | Approved |
July 12, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir
ANDA #209000 |
Acyclovir | Ointment; Topical | SUPPL-1 | Alembic Pharms Ltd | Manufacturing (CMC) | Approved |
| Aemcolo
NDA #210910 |
Rifamycin | Tablet, Delayed Release; Oral | SUPPL-1 | Cosmo Technologies | Labeling | Approved |
| Avonex
BLA #103628 |
Interferon Beta-1a | Vial | SUPPL-5264 | Biogen | Labeling | Approved |
| Avonex
BLA #103628 |
Interferon Beta-1a | Vial | SUPPL-5264 | Biogen | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #076931 |
Buprenorphine Hydrochloride | Injectable; Injection | SUPPL-11 | West-Ward Pharms Int | Manufacturing (CMC) | Approved |
| Cerebyx
NDA #020450 |
Fosphenytoin Sodium | Injectable; Injection | SUPPL-39 | Parke Davis | Labeling | Approved |
| Daptomycin
ANDA #212667 |
Daptomycin | Powder; Iv (Infusion) | ORIG-1 | Accord Hlthcare | Approved | |
| Dilantin-125
NDA #008762 |
Phenytoin | Suspension; Oral | SUPPL-63 | Parke Davis | Labeling | Approved |
| Dilantin-30
NDA #008762 |
Phenytoin | Suspension; Oral | SUPPL-63 | Parke Davis | Labeling | Approved |
| Ethacrynic Acid
ANDA #211809 |
Ethacrynic Acid | Tablet; Oral | ORIG-1 | Agnitio | Approved | |
| Gadavist
NDA #201277 |
Gadobutrol | Solution; Intravenous | SUPPL-17 | Bayer Hlthcare | Efficacy | Approved |
| Isosulfan Blue
ANDA #210558 |
Isosulfan Blue | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Ivermectin
ANDA #212485 |
Ivermectin | Unknown | ORIG-1 | Teva Pharms Usa | Tentative Approval | |
| Jeuveau
BLA #761085 |
Prabotulinumtoxina-Xvfs | Injectable; Injection | SUPPL-1 | Evolus Inc | Labeling | Approved |
| Sildenafil
ANDA #212440 |
Sildenafil | Unknown | ORIG-1 | Alkem Labs Ltd | Tentative Approval | |
| Technetium Tc99m Mertiatide Kit
ANDA #208994 |
Technetium Tc-99m Mertiatide Kit | Injectable; Injection | ORIG-1 | Pharmalucence | Approved |
July 11, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albenza
NDA #020666 |
Albendazole | Tablet; Oral | SUPPL-12 | Impax Labs Inc | Labeling | Approved |
July 10, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abiraterone Acetate
ANDA #210686 |
Abiraterone Acetate | Tablet; Oral | ORIG-1 | Msn Labs Pvt Ltd | Approved | |
| Clobazam
ANDA #210746 |
Clobazam | Suspension; Oral | ORIG-1 | Vistapharm | Approved | |
| Cyclosporine
ANDA #210721 |
Cyclosporine | Capsule; Oral | ORIG-1 | Apotex Inc | Approved | |
| Intelence
NDA #022187 |
Etravirine | Tablet; Oral | SUPPL-25 | Janssen R and D | Labeling | Approved |
| Intelence
NDA #022187 |
Etravirine | Tablet; Oral | SUPPL-25 | Janssen R and D | Labeling | Approved |
| Omega-3-Acid Ethyl Esters
ANDA #211355 |
Omega-3-Acid Ethyl Esters | Capsule; Oral | ORIG-1 | Sofgen Pharms | Approved | |
| Plegridy
BLA #125499 |
Peginterferon Beta-1a | Injectable; Injection | SUPPL-19 | Biogen Idec Inc | Labeling | Approved |
| Plegridy
BLA #125499 |
Peginterferon Beta-1a | Injectable; Injection | SUPPL-19 | Biogen Idec Inc | Labeling | Approved |
| Potassium Chloride
NDA #208019 |
Potassium Chloride | For Solution; Oral | SUPPL-2 | Pharma Res Software | Labeling | Approved |
| Sorafenib Tosylate
ANDA #209050 |
Sorafenib Tosylate | Unknown | ORIG-1 | Yabao Pharm | Tentative Approval | |
| Tecfidera
NDA #204063 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-24 | Biogen Idec Inc | Labeling | Approved |
| Triferic
NDA #206317 |
Ferric Pyrophosphate Citrate | Solution; Intravenous | SUPPL-12 | Rockwell Medical Inc | Labeling | Approved |
July 9, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adapalene
ANDA #091314 |
Adapalene | Gel; Topical | SUPPL-5 | Glenmark Generics | Labeling | Approved |
| Adapalene
ANDA #091314 |
Adapalene | Gel; Topical | SUPPL-5 | Glenmark Generics | Labeling | Approved |
| Advil Allergy and Congestion Relief
NDA #022113 |
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride | Tablet; Oral | SUPPL-7 | Pfizer | Labeling | Approved |
| Advil Congestion Relief
NDA #022565 |
Ibuprofen; Phenylephrine Hydrochloride | Tablet; Oral | SUPPL-5 | Pfizer | Labeling | Approved |
| Advil Multi-Symptom Cold & Flu
NDA #022113 |
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride | Tablet; Oral | SUPPL-7 | Pfizer | Labeling | Approved |
| Atropine (Autoinjector)
NDA #212319 |
Atropine | Solution; Intramuscular | SUPPL-2 | Rafa Labs Ltd | Labeling | Approved |
| Bupivacaine Hydrochloride Preservative Free
ANDA #203895 |
Bupivacaine Hydrochloride | Injectable; Injection | SUPPL-2 | Aurobindo Pharma Ltd | Labeling | Approved |
| Docetaxel
NDA #203551 |
Docetaxel | Injectable; Injection | SUPPL-7 | Actavis Llc | Labeling | Approved |
| Docetaxel
NDA #203551 |
Docetaxel | Injectable; Injection | SUPPL-7 | Actavis Llc | Labeling | Approved |
| Imipenem and Cilastatin
ANDA #090577 |
Cilastatin Sodium; Imipenem | Powder; Intravenous | SUPPL-10 | Acs Dobfar | Labeling | Approved |
| Imipenem and Cilastatin
ANDA #090577 |
Cilastatin Sodium; Imipenem | Powder; Intravenous | SUPPL-12 | Acs Dobfar | Labeling | Approved |
| Rebif
BLA #103780 |
Interferon Beta-1a | Syringe | SUPPL-5204 | Serono Inc | Labeling | Approved |
| Rebif
BLA #103780 |
Interferon Beta-1a | Syringe | SUPPL-5204 | Serono Inc | Labeling | Approved |
| Risedronate Sodium
ANDA #203925 |
Risedronate Sodium | Tablet, Delayed Release; Oral | ORIG-1 | Sun Pharm | Approved | |
| Sildenafil Citrate
ANDA #211092 |
Sildenafil Citrate | Unknown | ORIG-1 | Amneal Pharms Ny | Tentative Approval | |
| Telmisartan
ANDA #205150 |
Telmisartan | Tablet; Oral | SUPPL-7 | Inventia Hlthcare | Labeling | Approved |
| Telmisartan
ANDA #205150 |
Telmisartan | Tablet; Oral | SUPPL-5 | Inventia Hlthcare | Labeling | Approved |
| Telmisartan
ANDA #205150 |
Telmisartan | Tablet; Oral | SUPPL-7 | Inventia Hlthcare | Labeling | Approved |
| Voriconazole
ANDA #200265 |
Voriconazole | Tablet; Oral | SUPPL-10 | Sandoz Inc | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-1 | Cadila | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-2 | Cadila | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-4 | Cadila | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-1 | Cadila | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-2 | Cadila | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-3 | Cadila | Labeling | Approved |
| Voriconazole
ANDA #206747 |
Voriconazole | Tablet; Oral | SUPPL-4 | Cadila | Labeling | Approved |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English