Drugs@FDA: FDA-Approved Drugs

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

7 Day Report
14 Day Report

April 16, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Opdivo BLA #125554	Nivolumab	Injectable; Injection	SUPPL-91	Bristol Myers Squibb	Labeling	Approved

April 15, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Emtricitabine; Tenofovir Disoproxil Fumarate ANDA #208740	Emtricitabine;Tenofovir Disoproxil Fumarate	Unknown	ORIG-1	Apotex Inc		Tentative Approval
Nextstellis NDA #214154	Drospirenone;Estetrol	Tablet, Chewable, Tablet, Capsule; Oral	ORIG-1	Mayne Pharma	Type 1 - New Molecular Entity	Approved
Tobramycin Sulfate NDA #050789	Tobramycin Sulfate	Injectable; Injection	SUPPL-12	Fresenius Kabi Usa	Labeling	Approved
Vfend NDA #021266	Voriconazole	Tablet; Oral	SUPPL-50	Pf Prism Cv	Labeling	Approved
Vfend NDA #021267	Voriconazole	Injectable; Intravenous	SUPPL-60	Pf Prism Cv	Labeling	Approved
Vfend NDA #021630	Voriconazole	For Suspension; Oral	SUPPL-39	Pf Prism Cv	Labeling	Approved

April 14, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Alaway NDA #021996	Ketotifen Fumarate	Solution/Drops; Ophthalmic	SUPPL-17	Bausch and Lomb	Labeling	Approved
Bortezomib NDA #209191	Bortezomib	Powder; Intravenous, Subcutaneous	ORIG-1	Hospira Inc	Type 5 - New Formulation or New Manufacturer	Tentative Approval
Budesonide ANDA #211922	Budesonide	Suspension; Inhalation	ORIG-1	Sun Pharm		Approved
Contrave NDA #200063	Bupropion Hydrochloride; Naltrexone Hydrochloride	Tablet, Extended Release; Oral	SUPPL-20	Nalpropion	Labeling	Approved
Contrave NDA #200063	Bupropion Hydrochloride; Naltrexone Hydrochloride	Tablet, Extended Release; Oral	SUPPL-20	Nalpropion	Labeling	Approved
Polyethylene Glycol 3350 ANDA #214990	Polyethylene Glycol 3350	For Solution; Oral	ORIG-1	Annora Pharma		Approved

April 13, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Carbamazepine ANDA #213311	Carbamazepine	Tablet, Extended Release; Oral	ORIG-1	Cspc Ouyi		Approved
Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 2.75/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/20 Sulfite Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/15 Sulfite Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/20 Sulfite Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/35 Sulfite Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinolipid 20% NDA #204508	Olive Oil; Soybean Oil	Emulsion; Intravenous	SUPPL-15	Baxter Hlthcare Corp	Labeling	Approved
Ibuprofen ANDA #209178	Ibuprofen	Suspension; Oral	SUPPL-6	Aurobindo Pharma Ltd	Labeling	Approved
Indomethacin ANDA #070900	Indomethacin	Capsule; Oral	SUPPL-23	Sun Pharm Industries	Labeling	Approved
Kyleena NDA #208224	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-2	Bayer Hlthcare	Labeling	Approved
Kyleena NDA #208224	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-2	Bayer Hlthcare	Labeling	Approved
Kyleena NDA #208224	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-2	Bayer Hlthcare	Labeling	Approved
Levetiracetam In Sodium Chloride NDA #202543	Levetiracetam	Injectable; Intravenous	SUPPL-19	Hq Speciality Pharma	Labeling	Approved
Pregabalin ANDA #211593	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Alvogen Pine Brook		Approved
Pregabalin ANDA #211889	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Sun Pharm		Approved
Pregabalin ANDA #211948	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Mylan		Approved
Pregabalin ANDA #213226	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Msn		Approved
Pregabalin ANDA #213313	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Apotex		Approved
Proscar NDA #020180	Finasteride	Tablet; Oral	SUPPL-48	Merck	Labeling	Approved
Tadalafil ANDA #206286	Tadalafil	Tablet; Oral	SUPPL-2	Aurobindo Pharma Ltd	Labeling	Approved
Tecentriq BLA #761034	Atezolizumab	Injectable; Injection	SUPPL-41	Genentech Inc	Labeling	Approved
Trodelvy BLA #761115	Sacituzumab Govitecan-Hziy	Injectable; Injection	SUPPL-9	Immunomedics Inc	Efficacy	Approved
Trulance NDA #208745	Plecanatide	Tablet; Oral	SUPPL-11	Salix	Labeling	Approved
Xiaflex BLA #125338	Collagenase Clostridium Histolyticum	Solution; Injection	SUPPL-112	Auxilium Pharms	Labeling	Approved
Xiaflex BLA #125338	Collagenase Clostridium Histolyticum	Solution; Injection	SUPPL-112	Auxilium Pharms	Labeling	Approved

April 12, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Benzoyl Peroxide; Clindamycin Phosphate ANDA #208757	Benzoyl Peroxide;Clindamycin Phosphate	Unknown	ORIG-1	Actavis Labs Ut Inc		Tentative Approval
Decitabine ANDA #212826	Decitabine	Injectable; Intravenous	ORIG-1	Qilu		Approved
Diclofenac Potassium ANDA #076561	Diclofenac Potassium	Tablet; Oral	SUPPL-11	Amici	Manufacturing (CMC)	Approved
Isotretinoin ANDA #213571	Isotretinoin	Capsule; Oral	ORIG-1	Upsher Smith Labs		Approved
Linzess NDA #202811	Linaclotide	Capsule; Oral	SUPPL-17	Allergan	Labeling	Approved
Ozempic NDA #209637	Semaglutide	Solution; Subcutaneous	SUPPL-8	Novo	Labeling	Approved

April 9, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Clozapine ANDA #090308	Clozapine	Tablet, Orally Disintegrating; Oral	SUPPL-1	Barr Labs Inc	Labeling	Approved
Definity NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-25	Lantheus Medcl	Labeling	Approved
Definity NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-29	Lantheus Medcl	Labeling	Approved
Definity Rt NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-25	Lantheus Medcl	Labeling	Approved
Definity Rt NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-29	Lantheus Medcl	Labeling	Approved
Epifoam ANDA #086457	Hydrocortisone Acetate; Pramoxine Hydrochloride	Aerosol, Metered; Topical	SUPPL-34	Mylan Speciality Lp	Manufacturing (CMC)	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-9	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-10	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-11	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-9	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-10	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-11	Teva	Labeling	Approved
Ibrutinib ANDA #212763	Ibrutinib	Unknown	ORIG-1	Alvogen Pine Brook		Tentative Approval
Lumason NDA #203684	Sulfur Hexafluoride Lipid-Type A Microspheres	For Suspension; Intravenous	SUPPL-9	Bracco	Labeling	Approved
Norepinephrine Bitartrate ANDA #211242	Norepinephrine Bitartrate	Injectable; Injection	SUPPL-4	Mylan Labs Ltd	Labeling	Approved
Norepinephrine Bitartrate ANDA #211242	Norepinephrine Bitartrate	Injectable; Injection	SUPPL-4	Mylan Labs Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-5	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-9	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-11	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-5	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-9	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-11	Natco Pharma Ltd	Labeling	Approved
Xolair BLA #103976	Omalizumab	Vial	SUPPL-5238	Genentech	Efficacy	Approved

April 16, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Opdivo BLA #125554	Nivolumab	Injectable; Injection	SUPPL-91	Bristol Myers Squibb	Labeling	Approved

April 15, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Emtricitabine; Tenofovir Disoproxil Fumarate ANDA #208740	Emtricitabine;Tenofovir Disoproxil Fumarate	Unknown	ORIG-1	Apotex Inc		Tentative Approval
Nextstellis NDA #214154	Drospirenone;Estetrol	Tablet, Chewable, Tablet, Capsule; Oral	ORIG-1	Mayne Pharma	Type 1 - New Molecular Entity	Approved
Tobramycin Sulfate NDA #050789	Tobramycin Sulfate	Injectable; Injection	SUPPL-12	Fresenius Kabi Usa	Labeling	Approved
Vfend NDA #021266	Voriconazole	Tablet; Oral	SUPPL-50	Pf Prism Cv	Labeling	Approved
Vfend NDA #021267	Voriconazole	Injectable; Intravenous	SUPPL-60	Pf Prism Cv	Labeling	Approved
Vfend NDA #021630	Voriconazole	For Suspension; Oral	SUPPL-39	Pf Prism Cv	Labeling	Approved

April 14, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Alaway NDA #021996	Ketotifen Fumarate	Solution/Drops; Ophthalmic	SUPPL-17	Bausch and Lomb	Labeling	Approved
Bortezomib NDA #209191	Bortezomib	Powder; Intravenous, Subcutaneous	ORIG-1	Hospira Inc	Type 5 - New Formulation or New Manufacturer	Tentative Approval
Budesonide ANDA #211922	Budesonide	Suspension; Inhalation	ORIG-1	Sun Pharm		Approved
Contrave NDA #200063	Bupropion Hydrochloride; Naltrexone Hydrochloride	Tablet, Extended Release; Oral	SUPPL-20	Nalpropion	Labeling	Approved
Contrave NDA #200063	Bupropion Hydrochloride; Naltrexone Hydrochloride	Tablet, Extended Release; Oral	SUPPL-20	Nalpropion	Labeling	Approved
Polyethylene Glycol 3350 ANDA #214990	Polyethylene Glycol 3350	For Solution; Oral	ORIG-1	Annora Pharma		Approved

April 13, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Carbamazepine ANDA #213311	Carbamazepine	Tablet, Extended Release; Oral	ORIG-1	Cspc Ouyi		Approved
Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Container NDA #020734	Amino Acids; Dextrose	Injectable; Injection	SUPPL-37	Baxter Hlthcare	Labeling	Approved
Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 2.75/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/20 Sulfite Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 4.25/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/15 Sulfite Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/20 Sulfite Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinimix E 5/35 Sulfite Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container NDA #020678	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Injectable; Injection	SUPPL-42	Baxter Hlthcare	Labeling	Approved
Clinolipid 20% NDA #204508	Olive Oil; Soybean Oil	Emulsion; Intravenous	SUPPL-15	Baxter Hlthcare Corp	Labeling	Approved
Ibuprofen ANDA #209178	Ibuprofen	Suspension; Oral	SUPPL-6	Aurobindo Pharma Ltd	Labeling	Approved
Indomethacin ANDA #070900	Indomethacin	Capsule; Oral	SUPPL-23	Sun Pharm Industries	Labeling	Approved
Kyleena NDA #208224	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-2	Bayer Hlthcare	Labeling	Approved
Kyleena NDA #208224	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-2	Bayer Hlthcare	Labeling	Approved
Kyleena NDA #208224	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-2	Bayer Hlthcare	Labeling	Approved
Levetiracetam In Sodium Chloride NDA #202543	Levetiracetam	Injectable; Intravenous	SUPPL-19	Hq Speciality Pharma	Labeling	Approved
Pregabalin ANDA #211593	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Alvogen Pine Brook		Approved
Pregabalin ANDA #211889	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Sun Pharm		Approved
Pregabalin ANDA #211948	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Mylan		Approved
Pregabalin ANDA #213226	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Msn		Approved
Pregabalin ANDA #213313	Pregabalin	Tablet, Extended Release; Oral	ORIG-1	Apotex		Approved
Proscar NDA #020180	Finasteride	Tablet; Oral	SUPPL-48	Merck	Labeling	Approved
Tadalafil ANDA #206286	Tadalafil	Tablet; Oral	SUPPL-2	Aurobindo Pharma Ltd	Labeling	Approved
Tecentriq BLA #761034	Atezolizumab	Injectable; Injection	SUPPL-41	Genentech Inc	Labeling	Approved
Trodelvy BLA #761115	Sacituzumab Govitecan-Hziy	Injectable; Injection	SUPPL-9	Immunomedics Inc	Efficacy	Approved
Trulance NDA #208745	Plecanatide	Tablet; Oral	SUPPL-11	Salix	Labeling	Approved
Xiaflex BLA #125338	Collagenase Clostridium Histolyticum	Solution; Injection	SUPPL-112	Auxilium Pharms	Labeling	Approved
Xiaflex BLA #125338	Collagenase Clostridium Histolyticum	Solution; Injection	SUPPL-112	Auxilium Pharms	Labeling	Approved

April 12, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Benzoyl Peroxide; Clindamycin Phosphate ANDA #208757	Benzoyl Peroxide;Clindamycin Phosphate	Unknown	ORIG-1	Actavis Labs Ut Inc		Tentative Approval
Decitabine ANDA #212826	Decitabine	Injectable; Intravenous	ORIG-1	Qilu		Approved
Diclofenac Potassium ANDA #076561	Diclofenac Potassium	Tablet; Oral	SUPPL-11	Amici	Manufacturing (CMC)	Approved
Isotretinoin ANDA #213571	Isotretinoin	Capsule; Oral	ORIG-1	Upsher Smith Labs		Approved
Linzess NDA #202811	Linaclotide	Capsule; Oral	SUPPL-17	Allergan	Labeling	Approved
Ozempic NDA #209637	Semaglutide	Solution; Subcutaneous	SUPPL-8	Novo	Labeling	Approved

April 9, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Clozapine ANDA #090308	Clozapine	Tablet, Orally Disintegrating; Oral	SUPPL-1	Barr Labs Inc	Labeling	Approved
Definity NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-25	Lantheus Medcl	Labeling	Approved
Definity NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-29	Lantheus Medcl	Labeling	Approved
Definity Rt NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-25	Lantheus Medcl	Labeling	Approved
Definity Rt NDA #021064	Perflutren	Injectable; Intravenous	SUPPL-29	Lantheus Medcl	Labeling	Approved
Epifoam ANDA #086457	Hydrocortisone Acetate; Pramoxine Hydrochloride	Aerosol, Metered; Topical	SUPPL-34	Mylan Speciality Lp	Manufacturing (CMC)	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-9	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-10	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-11	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-9	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-10	Teva	Labeling	Approved
Fluconazole ANDA #074681	Fluconazole	Tablet; Oral	SUPPL-11	Teva	Labeling	Approved
Ibrutinib ANDA #212763	Ibrutinib	Unknown	ORIG-1	Alvogen Pine Brook		Tentative Approval
Lumason NDA #203684	Sulfur Hexafluoride Lipid-Type A Microspheres	For Suspension; Intravenous	SUPPL-9	Bracco	Labeling	Approved
Norepinephrine Bitartrate ANDA #211242	Norepinephrine Bitartrate	Injectable; Injection	SUPPL-4	Mylan Labs Ltd	Labeling	Approved
Norepinephrine Bitartrate ANDA #211242	Norepinephrine Bitartrate	Injectable; Injection	SUPPL-4	Mylan Labs Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-5	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-9	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-11	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-5	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-9	Natco Pharma Ltd	Labeling	Approved
Oseltamivir Phosphate ANDA #202595	Oseltamivir Phosphate	Capsule; Oral	SUPPL-11	Natco Pharma Ltd	Labeling	Approved
Xolair BLA #103976	Omalizumab	Vial	SUPPL-5238	Genentech	Efficacy	Approved

April 8, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Aminocaproic Acid ANDA #213825	Aminocaproic Acid	Solution; Oral	ORIG-1	Airis Pharma Pvt Ltd		Approved
Byfavo NDA #212295	Remimazolam Besylate	Powder; Intravenous	SUPPL-2	Acacia	Labeling	Approved
Nicardipine Hydrochloride ANDA #211121	Nicardipine Hydrochloride	Injectable; Injection	ORIG-1	Aurobindo Pharma Ltd		Approved
Pantoprazole Sodium ANDA #208580	Pantoprazole Sodium	Injectable; Iv (Infusion)	SUPPL-1	Mylan Labs Ltd	Labeling	Approved
Pantoprazole Sodium ANDA #208580	Pantoprazole Sodium	Injectable; Iv (Infusion)	SUPPL-2	Mylan Labs Ltd	Labeling	Approved
Pantoprazole Sodium ANDA #208580	Pantoprazole Sodium	Injectable; Iv (Infusion)	SUPPL-3	Mylan Labs Ltd	Labeling	Approved
Pimavanserin ANDA #214750	Pimavanserin	Unknown	ORIG-1	Teva Pharms Usa		Tentative Approval
Tirofiban Hydrochloride ANDA #206888	Tirofiban Hydrochloride	Solution; Intravenous	ORIG-1	Gland Pharma Ltd		Approved
Ztlido NDA #207962	Lidocaine	Patch; Topical	SUPPL-5	Scilex Pharms Inc	Efficacy	Approved

April 7, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Efinaconazole ANDA #212027	Efinaconazole	Unknown	ORIG-1	Aleor Dermaceuticals		Tentative Approval
Exforge NDA #021990	Amlodipine Besylate; Valsartan	Tablet; Oral	SUPPL-41	Novartis	Labeling	Approved
Ketamine Hydrochloride ANDA #074524	Ketamine Hydrochloride	Injectable; Injection	SUPPL-18	West-Ward Pharms Int	Labeling	Approved
Rizatriptan Benzoate ANDA #078173	Rizatriptan Benzoate	Tablet, Orally Disintegrating; Oral	SUPPL-7	Mylan Pharms Inc	Labeling	Approved
Rizatriptan Benzoate ANDA #078173	Rizatriptan Benzoate	Tablet, Orally Disintegrating; Oral	SUPPL-7	Mylan Pharms Inc	Labeling	Approved
Rizatriptan Benzoate ANDA #078173	Rizatriptan Benzoate	Tablet, Orally Disintegrating; Oral	SUPPL-7	Mylan Pharms Inc	Labeling	Approved
Selexipag ANDA #214367	Selexipag	Unknown	ORIG-1	Msn Laboratories Private Ltd		Tentative Approval
Teriflunomide ANDA #209638	Teriflunomide	Tablet; Oral	SUPPL-4	Aurobindo Pharma Ltd	Labeling	Approved
Teriflunomide ANDA #209638	Teriflunomide	Tablet; Oral	SUPPL-4	Aurobindo Pharma Ltd	Labeling	Approved
Teriflunomide ANDA #209663	Teriflunomide	Tablet; Oral	SUPPL-3	Glenmark Pharms	Labeling	Approved
Trodelvy BLA #761115	Sacituzumab Govitecan-Hziy	Injectable; Injection	SUPPL-5	Immunomedics Inc	Efficacy	Approved
Trodelvy BLA #761115	Sacituzumab Govitecan-Hziy	Injectable; Injection	SUPPL-13	Immunomedics Inc	Efficacy	Approved
Vancomycin Hydrochloride ANDA #091554	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-14	Mylan Labs Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #091554	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-15	Mylan Labs Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #212332	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-3	Hainan Poly Pharm	Labeling	Approved
Vilazodone Hydrochloride ANDA #208200	Vilazodone Hydrochloride	Tablet; Oral	ORIG-1	Invagen Pharms		Approved
Vilazodone Hydrochloride ANDA #208200	Vilazodone Hydrochloride	Tablet; Oral	ORIG-2	Invagen Pharms		Tentative Approval

April 6, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Budesonide ANDA #205710	Budesonide	Suspension; Inhalation	SUPPL-9	Cipla	Labeling	Approved
Erbitux BLA #125084	Cetuximab	Vial; Intravenous	SUPPL-277	Imclone	Efficacy	Approved
Erbitux BLA #125084	Cetuximab	Vial; Intravenous	SUPPL-280	Imclone	Efficacy	Approved
Fulvestrant NDA #210063	Fulvestrant	Solution; Intramuscular	SUPPL-2	Teva Pharms Usa Inc	Labeling	Approved
Macitentan ANDA #211224	Macitentan	Tablet; Oral	ORIG-1	Zydus		Approved
Oxymetazoline Hydrochloride ANDA #213584	Oxymetazoline Hydrochloride	Unknown	ORIG-1	Taro Pharms		Tentative Approval
Tranexamic Acid ANDA #205035	Tranexamic Acid	Injectable; Injection	SUPPL-4	Aurobindo Pharma Ltd	Labeling	Approved

April 5, 2021

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Abiraterone Acetate ANDA #209227	Abiraterone Acetate	Tablet; Oral	SUPPL-2	Glenmark Pharms	Labeling	Approved
Abiraterone Acetate ANDA #209227	Abiraterone Acetate	Tablet; Oral	SUPPL-2	Glenmark Pharms	Labeling	Approved
Abiraterone Acetate ANDA #210686	Abiraterone Acetate	Tablet; Oral	SUPPL-2	Msn	Labeling	Approved
Abiraterone Acetate ANDA #210686	Abiraterone Acetate	Tablet; Oral	SUPPL-2	Msn	Labeling	Approved
Abiraterone Acetate ANDA #212462	Abiraterone Acetate	Tablet; Oral	SUPPL-1	Qilu	Labeling	Approved
Amlodipine Besylate, Valsartan and Hydrochlorothiazide ANDA #201087	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-1	Par Pharm	Labeling	Approved
Amlodipine Besylate, Valsartan and Hydrochlorothiazide ANDA #201087	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-6	Par Pharm	Labeling	Approved
Amlodipine Besylate, Valsartan and Hydrochlorothiazide ANDA #201087	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-7	Par Pharm	Labeling	Approved
Amlodipine Besylate, Valsartan and Hydrochlorothiazide ANDA #201087	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-7	Par Pharm	Labeling	Approved
Levetiracetam ANDA #091291	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-6	Virtus Pharms	Labeling	Approved
Levetiracetam ANDA #091291	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-7	Virtus Pharms	Labeling	Approved
Levetiracetam ANDA #091291	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-5	Virtus Pharms	Labeling	Approved
Levetiracetam ANDA #091291	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-6	Virtus Pharms	Labeling	Approved
Levetiracetam ANDA #091291	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-7	Virtus Pharms	Labeling	Approved
Levetiracetam ANDA #091291	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-7	Virtus Pharms	Labeling	Approved
Levetiracetam ANDA #207175	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-2	Hisun Pharm Hangzhou	Labeling	Approved
Levetiracetam ANDA #207175	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-1	Hisun Pharm Hangzhou	Labeling	Approved
Levetiracetam ANDA #207175	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-2	Hisun Pharm Hangzhou	Labeling	Approved
Levetiracetam ANDA #207175	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-3	Hisun Pharm Hangzhou	Labeling	Approved
Levocetirizine Dihydrochloride ANDA #090392	Levocetirizine Dihydrochloride	Tablet; Oral	SUPPL-4	Dr Reddys Labs Ltd	Labeling	Approved
Levocetirizine Dihydrochloride ANDA #090392	Levocetirizine Dihydrochloride	Tablet; Oral	SUPPL-5	Dr Reddys Labs Ltd	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-4	Teva Pharms Usa	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-4	Teva Pharms Usa	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-4	Teva Pharms Usa	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Naloxone Hydrochloride ANDA #209522	Naloxone Hydrochloride	Spray, Metered; Nasal	SUPPL-4	Teva Pharms Usa	Labeling	Approved
Neostigmine Methylsulfate ANDA #212804	Neostigmine Methylsulfate	Solution; Intravenous	ORIG-1	Hong Kong		Approved
Regonol NDA #017398	Pyridostigmine Bromide	Injectable; Injection	SUPPL-25	Sandoz Inc	Labeling	Approved
Regonol NDA #017398	Pyridostigmine Bromide	Injectable; Injection	SUPPL-25	Sandoz Inc	Labeling	Approved
Tolmetin Sodium ANDA #073462	Tolmetin Sodium	Capsule; Oral	SUPPL-5	Fosun Pharma	Labeling	Approved
Tolmetin Sodium ANDA #073462	Tolmetin Sodium	Capsule; Oral	SUPPL-5	Fosun Pharma	Labeling	Approved
Tolmetin Sodium ANDA #073588	Tolmetin Sodium	Tablet; Oral	SUPPL-3	Fosun Pharma	Labeling	Approved
Tolmetin Sodium ANDA #073588	Tolmetin Sodium	Tablet; Oral	SUPPL-3	Fosun Pharma	Labeling	Approved
Tolmetin Sodium ANDA #074002	Tolmetin Sodium	Tablet; Oral	SUPPL-2	Fosun Pharma	Labeling	Approved
Tolmetin Sodium ANDA #074002	Tolmetin Sodium	Tablet; Oral	SUPPL-2	Fosun Pharma	Labeling	Approved