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.

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

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