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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.

August 17, 2022

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Actiq
NDA #020747
Fentanyl Citrate Troche/Lozenge; Transmucosal SUPPL-58 Cephalon REMS Approved
Fentanyl Citrate
ANDA #078907
Fentanyl Citrate Troche/Lozenge; Transmucosal SUPPL-24 Specgx Llc REMS Approved
Fentanyl Citrate
ANDA #079075
Fentanyl Citrate Tablet; Buccal, Sublingual SUPPL-16 Watson Labs REMS Approved
Fentanyl Citrate
ANDA #207338
Fentanyl Citrate Tablet; Sublingual SUPPL-3 Actavis Labs Fl Inc REMS Approved
Fentora
NDA #021947
Fentanyl Citrate Tablet; Buccal, Sublingual SUPPL-40 Cephalon REMS Approved
Lazanda
NDA #022569
Fentanyl Citrate Spray, Metered; Nasal SUPPL-32 Btcp Pharma REMS Approved
Naproxen Sodium
ANDA #215472
Naproxen Sodium Capsule; Oral ORIG-1 Strides Pharma Approved
Onsolis
NDA #022266
Fentanyl Citrate Film; Buccal SUPPL-27 Bdsi REMS Approved
Rufinamide
ANDA #204964
Rufinamide Tablet; Oral ORIG-1 Lupin Ltd Approved
Subsys
NDA #202788
Fentanyl Spray; Sublingual SUPPL-29 Btcp Pharma REMS Approved
Valsartan
ANDA #203536
Valsartan Tablet; Oral SUPPL-16 Jubilant Generics Manufacturing (CMC) Approved
Valsartan
ANDA #203536
Valsartan Tablet; Oral SUPPL-16 Jubilant Generics Manufacturing (CMC) Approved

August 16, 2022

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bendamustine Hydrochloride
ANDA #205376
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Dr Reddys Labs Ltd Tentative Approval
Butalbital and Acetaminophen
ANDA #214955
Acetaminophen; Butalbital Tablet; Oral ORIG-1 Aace Pharms Approved
Enbrel
BLA #103795
Etanercept Syringe SUPPL-5591 Immunex Labeling Approved
Enbrel
BLA #103795
Etanercept Vial; Subcutaneous SUPPL-5591 Immunex Labeling Approved
Ethosuximide
ANDA #210654
Ethosuximide Capsule; Oral SUPPL-2 Puracap Pharm Llc Labeling Approved
Ethosuximide
ANDA #210654
Ethosuximide Capsule; Oral SUPPL-2 Puracap Pharm Llc Labeling Approved
Ethosuximide
ANDA #210654
Ethosuximide Capsule; Oral SUPPL-2 Puracap Pharm Llc Labeling Approved
Ipratropium Bromide
ANDA #215104
Ipratropium Bromide Spray, Metered; Nasal ORIG-1 Amneal Approved
Ipratropium Bromide
ANDA #215105
Ipratropium Bromide Spray, Metered; Nasal ORIG-1 Amneal Approved
Metoprolol Succinate
ANDA #211143
Metoprolol Succinate Tablet, Extended Release; Oral SUPPL-2 Alkem Labs Ltd Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-4 Strides Pharma Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-3 Strides Pharma Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-4 Strides Pharma Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-3 Strides Pharma Labeling Approved
Repatha
BLA #125522
Evolocumab Injectable; Injection SUPPL-33 Amgen Inc Labeling Approved
Tobradex St
NDA #050818
Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic SUPPL-7 Eyevance Labeling Approved
Tobradex St
NDA #050818
Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic SUPPL-8 Eyevance Labeling Approved
Tobradex St
NDA #050818
Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic SUPPL-9 Eyevance Labeling Approved
Toujeo Max Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Toujeo Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Toujeo Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Vfend
NDA #021266
Voriconazole Tablet; Oral SUPPL-54 Pf Prism Cv Labeling Approved
Vfend
NDA #021267
Voriconazole Injectable; Intravenous SUPPL-64 Pf Prism Cv Labeling Approved
Vfend
NDA #021630
Voriconazole For Suspension; Oral SUPPL-43 Pf Prism Cv Labeling Approved
Voriconazole
NDA #208562
Voriconazole Injectable; Injection SUPPL-6 Xellia Pharms Aps Labeling Approved
Voriconazole
NDA #208562
Voriconazole Powder; Intravenous SUPPL-6 Xellia Pharms Aps Labeling Approved
Vuity
NDA #214028
Pilocarpine Hydrochloride Solution; Ophthalmic SUPPL-1 Abbvie Inc Labeling Approved
Xelstrym
NDA #215401
Dextroamphetamine System; Transdermal SUPPL-1 Noven Pharms Inc Labeling Approved

August 15, 2022

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aimovig
BLA #761077
Erenumab-Aooe Injectable; Injection SUPPL-16 Amgen Inc Labeling Approved
Byooviz
BLA #761202
Ranibizumab-Nuna Injectable; Injection SUPPL-3 Samsung Bioepis Co Ltd Labeling Approved
Clopidogrel Bisulfate
ANDA #077665
Clopidogrel Bisulfate Tablet; Oral SUPPL-13 Rising Labeling Approved
Clopidogrel Bisulfate
ANDA #077665
Clopidogrel Bisulfate Tablet; Oral SUPPL-13 Rising Labeling Approved
Cyanocobalamin
ANDA #213874
Cyanocobalamin Injectable; Injection SUPPL-3 Eugia Pharma Manufacturing (CMC) Approved
Cyanocobalamin
ANDA #213874
Cyanocobalamin Injectable; Injection SUPPL-3 Eugia Pharma Manufacturing (CMC) Approved
Dexamethasone
ANDA #080399
Dexamethasone Tablet; Oral SUPPL-79 Prasco Manufacturing (CMC) Approved
Effexor Xr
NDA #020699
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-112 Upjohn Labeling Approved
Epinephrine
NDA #211363
Epinephrine Injectable; Injection ORIG-1 Intl Medication Sys Type 7 - Drug Already Marketed without Approved NDA Approved
Hadlima
BLA #761059
Adalimumab-Bwwd Injectable; Injection SUPPL-5 Samsung Bioepis Co Ltd Efficacy Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202052
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Orbion Pharms Labeling Approved
Pantoprazole Sodium
ANDA #202052
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Orbion Pharms Labeling Approved
Pantoprazole Sodium
ANDA #202052
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-9 Orbion Pharms Labeling Approved
Quetiapine Fumarate
ANDA #215478
Quetiapine Fumarate Tablet, Extended Release; Oral ORIG-1 Unichem Approved
Vasopressin
ANDA #214314
Vasopressin Solution; Intravenous ORIG-1 Eugia Pharma Approved

August 12, 2022

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aprepitant
ANDA #211835
Aprepitant Capsule; Oral SUPPL-1 Torrent Labeling Approved
Aprepitant
ANDA #211835
Aprepitant Capsule; Oral SUPPL-1 Torrent Labeling Approved
Capecitabine
ANDA #200483
Capecitabine Tablet; Oral SUPPL-7 Hikma Labeling Approved
Cetrorelix Acetate
ANDA #215737
Cetrorelix Acetate Powder; Subcutaneous ORIG-1 Akorn Approved
Granisetron Hydrochloride
ANDA #077842
Granisetron Hydrochloride Tablet; Oral SUPPL-14 Hikma Labeling Approved
Granisetron Hydrochloride
ANDA #078080
Granisetron Hydrochloride Tablet; Oral SUPPL-8 Teva Pharms Labeling Approved
Isopto Atropine
NDA #208151
Atropine Sulfate Solution/Drops; Ophthalmic SUPPL-3 Alcon Labs Inc Manufacturing (CMC) Approved
Lisdexamfetamine Dimesylate
ANDA #202802
Lisdexamfetamine Dimesylate Capsule; Oral ORIG-1 Actavis Elizabeth Tentative Approval
Mirena
NDA #021225
Levonorgestrel Intrauterine Device; Intrauterine SUPPL-43 Bayer Hlthcare Efficacy Approved
Precedex
NDA #021038
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-31 Hospira Labeling Approved
Precedex
NDA #021038
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-33 Hospira Labeling Approved

August 11, 2022

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Brexpiprazole
ANDA #213692
Brexpiprazole Tablet; Oral ORIG-1 Teva Pharms Usa Inc Approved
Enhertu
BLA #761139
Fam-Trastuzumab Deruxtecan-Nxki Injectable; Injection SUPPL-21 Daiichi Sankyo Efficacy Approved
Meclizine Hydrochloride
ANDA #203003
Meclizine Hydrochloride Tablet; Oral ORIG-1 Lupin Ltd Approved
Memantine Hydrochloride
ANDA #214731
Memantine Hydrochloride Capsule, Extended Release; Oral ORIG-1 Novast Labs Ltd Tentative Approval
Nifedipine
ANDA #210012
Nifedipine Tablet, Extended Release; Oral SUPPL-3 Zydus Pharms Labeling Approved
Nifedipine
ANDA #210012
Nifedipine Tablet, Extended Release; Oral SUPPL-3 Zydus Pharms Labeling Approved
Nisoldipine
ANDA #079051
Nisoldipine Tablet, Extended Release; Oral SUPPL-5 Mylan Labeling Approved
Nisoldipine
ANDA #091001
Nisoldipine Tablet, Extended Release; Oral SUPPL-5 Mylan Labeling Approved
Nitazoxanide
ANDA #213820
Nitazoxanide Tablet; Oral SUPPL-2 Rising Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-25 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-20 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-23 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-25 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-26 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-20 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-21 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-23 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-25 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-26 Teva Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-26 Torrent Pharms Labeling Approved
Pirfenidone
ANDA #212759
Pirfenidone Tablet; Oral SUPPL-1 Teva Pharms Usa Labeling Approved
Pirfenidone
ANDA #212759
Pirfenidone Tablet; Oral SUPPL-1 Teva Pharms Usa Labeling Approved
Qutenza
NDA #022395
Capsaicin Patch; Topical SUPPL-21 Averitas Labeling Approved
Tadalafil
ANDA #210608
Tadalafil Tablet; Oral ORIG-1 Prinston Inc Approved
Tadalafil
ANDA #210609
Tadalafil Tablet; Oral ORIG-1 Prinston Inc Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-9 Genentech Inc Efficacy Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-5 Genentech Inc Efficacy Approved
Xofluza
NDA #214410
Baloxavir Marboxil For Suspension; Oral ORIG-2 Genentech Inc Efficacy Approved

August 10, 2022

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ampicillin Sodium
ANDA #090583
Ampicillin Sodium Injectable; Injection SUPPL-3 Sagent Pharms Inc Labeling Approved
Cellcept
NDA #050722
Mycophenolate Mofetil Capsule; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050722
Mycophenolate Mofetil Capsule; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050723
Mycophenolate Mofetil Tablet; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050723
Mycophenolate Mofetil Tablet; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050758
Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-48 Roche Palo Labeling Approved
Cellcept
NDA #050758
Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-48 Roche Palo Labeling Approved
Cellcept
NDA #050759
Mycophenolate Mofetil For Suspension; Oral SUPPL-55 Roche Palo Labeling Approved
Cellcept
NDA #050759
Mycophenolate Mofetil For Suspension; Oral SUPPL-55 Roche Palo Labeling Approved
Cromolyn Sodium
ANDA #075437
Cromolyn Sodium Solution; Inhalation SUPPL-1 Fera Pharms Llc Manufacturing (CMC) Approved
Cromolyn Sodium
ANDA #075437
Cromolyn Sodium Solution; Inhalation SUPPL-1 Fera Pharms Llc Manufacturing (CMC) Approved
Estradiol
ANDA #211783
Estradiol Gel; Transdermal ORIG-1 Chemo Research Sl Approved
Levofloxacin
ANDA #076710
Levofloxacin Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Levofloxacin
ANDA #076710
Levofloxacin Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Lidocaine and Prilocaine
ANDA #213923
Lidocaine; Prilocaine Cream; Topical SUPPL-1 Aleor Dermaceuticals Manufacturing (CMC) Approved
Tabrecta
NDA #213591
Capmatinib Hydrochloride Tablet; Oral SUPPL-4 Novartis Pharm Efficacy Approved
Trabectedin
ANDA #214837
Trabectedin Injectable; Injection ORIG-1 Natco Pharma Ltd Tentative Approval
Vasopressin
ANDA #212945
Vasopressin Injectable; Injection ORIG-1 Amneal Eu Ltd Tentative Approval

August 17, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Actiq
NDA #020747
Fentanyl Citrate Troche/Lozenge; Transmucosal SUPPL-58 Cephalon REMS Approved
Fentanyl Citrate
ANDA #078907
Fentanyl Citrate Troche/Lozenge; Transmucosal SUPPL-24 Specgx Llc REMS Approved
Fentanyl Citrate
ANDA #079075
Fentanyl Citrate Tablet; Buccal, Sublingual SUPPL-16 Watson Labs REMS Approved
Fentanyl Citrate
ANDA #207338
Fentanyl Citrate Tablet; Sublingual SUPPL-3 Actavis Labs Fl Inc REMS Approved
Fentora
NDA #021947
Fentanyl Citrate Tablet; Buccal, Sublingual SUPPL-40 Cephalon REMS Approved
Lazanda
NDA #022569
Fentanyl Citrate Spray, Metered; Nasal SUPPL-32 Btcp Pharma REMS Approved
Naproxen Sodium
ANDA #215472
Naproxen Sodium Capsule; Oral ORIG-1 Strides Pharma Approved
Onsolis
NDA #022266
Fentanyl Citrate Film; Buccal SUPPL-27 Bdsi REMS Approved
Rufinamide
ANDA #204964
Rufinamide Tablet; Oral ORIG-1 Lupin Ltd Approved
Subsys
NDA #202788
Fentanyl Spray; Sublingual SUPPL-29 Btcp Pharma REMS Approved
Valsartan
ANDA #203536
Valsartan Tablet; Oral SUPPL-16 Jubilant Generics Manufacturing (CMC) Approved
Valsartan
ANDA #203536
Valsartan Tablet; Oral SUPPL-16 Jubilant Generics Manufacturing (CMC) Approved

August 16, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bendamustine Hydrochloride
ANDA #205376
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Dr Reddys Labs Ltd Tentative Approval
Butalbital and Acetaminophen
ANDA #214955
Acetaminophen; Butalbital Tablet; Oral ORIG-1 Aace Pharms Approved
Enbrel
BLA #103795
Etanercept Syringe SUPPL-5591 Immunex Labeling Approved
Enbrel
BLA #103795
Etanercept Vial; Subcutaneous SUPPL-5591 Immunex Labeling Approved
Ethosuximide
ANDA #210654
Ethosuximide Capsule; Oral SUPPL-2 Puracap Pharm Llc Labeling Approved
Ethosuximide
ANDA #210654
Ethosuximide Capsule; Oral SUPPL-2 Puracap Pharm Llc Labeling Approved
Ethosuximide
ANDA #210654
Ethosuximide Capsule; Oral SUPPL-2 Puracap Pharm Llc Labeling Approved
Ipratropium Bromide
ANDA #215104
Ipratropium Bromide Spray, Metered; Nasal ORIG-1 Amneal Approved
Ipratropium Bromide
ANDA #215105
Ipratropium Bromide Spray, Metered; Nasal ORIG-1 Amneal Approved
Metoprolol Succinate
ANDA #211143
Metoprolol Succinate Tablet, Extended Release; Oral SUPPL-2 Alkem Labs Ltd Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-4 Strides Pharma Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-3 Strides Pharma Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-4 Strides Pharma Labeling Approved
Piroxicam
ANDA #210347
Piroxicam Capsule; Oral SUPPL-3 Strides Pharma Labeling Approved
Repatha
BLA #125522
Evolocumab Injectable; Injection SUPPL-33 Amgen Inc Labeling Approved
Tobradex St
NDA #050818
Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic SUPPL-7 Eyevance Labeling Approved
Tobradex St
NDA #050818
Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic SUPPL-8 Eyevance Labeling Approved
Tobradex St
NDA #050818
Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic SUPPL-9 Eyevance Labeling Approved
Toujeo Max Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Toujeo Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Toujeo Solostar
BLA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-16 Sanofi Us Services Labeling Approved
Vfend
NDA #021266
Voriconazole Tablet; Oral SUPPL-54 Pf Prism Cv Labeling Approved
Vfend
NDA #021267
Voriconazole Injectable; Intravenous SUPPL-64 Pf Prism Cv Labeling Approved
Vfend
NDA #021630
Voriconazole For Suspension; Oral SUPPL-43 Pf Prism Cv Labeling Approved
Voriconazole
NDA #208562
Voriconazole Injectable; Injection SUPPL-6 Xellia Pharms Aps Labeling Approved
Voriconazole
NDA #208562
Voriconazole Powder; Intravenous SUPPL-6 Xellia Pharms Aps Labeling Approved
Vuity
NDA #214028
Pilocarpine Hydrochloride Solution; Ophthalmic SUPPL-1 Abbvie Inc Labeling Approved
Xelstrym
NDA #215401
Dextroamphetamine System; Transdermal SUPPL-1 Noven Pharms Inc Labeling Approved

August 15, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aimovig
BLA #761077
Erenumab-Aooe Injectable; Injection SUPPL-16 Amgen Inc Labeling Approved
Byooviz
BLA #761202
Ranibizumab-Nuna Injectable; Injection SUPPL-3 Samsung Bioepis Co Ltd Labeling Approved
Clopidogrel Bisulfate
ANDA #077665
Clopidogrel Bisulfate Tablet; Oral SUPPL-13 Rising Labeling Approved
Clopidogrel Bisulfate
ANDA #077665
Clopidogrel Bisulfate Tablet; Oral SUPPL-13 Rising Labeling Approved
Cyanocobalamin
ANDA #213874
Cyanocobalamin Injectable; Injection SUPPL-3 Eugia Pharma Manufacturing (CMC) Approved
Cyanocobalamin
ANDA #213874
Cyanocobalamin Injectable; Injection SUPPL-3 Eugia Pharma Manufacturing (CMC) Approved
Dexamethasone
ANDA #080399
Dexamethasone Tablet; Oral SUPPL-79 Prasco Manufacturing (CMC) Approved
Effexor Xr
NDA #020699
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-112 Upjohn Labeling Approved
Epinephrine
NDA #211363
Epinephrine Injectable; Injection ORIG-1 Intl Medication Sys Type 7 - Drug Already Marketed without Approved NDA Approved
Hadlima
BLA #761059
Adalimumab-Bwwd Injectable; Injection SUPPL-5 Samsung Bioepis Co Ltd Efficacy Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202052
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Orbion Pharms Labeling Approved
Pantoprazole Sodium
ANDA #202052
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Orbion Pharms Labeling Approved
Pantoprazole Sodium
ANDA #202052
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-9 Orbion Pharms Labeling Approved
Quetiapine Fumarate
ANDA #215478
Quetiapine Fumarate Tablet, Extended Release; Oral ORIG-1 Unichem Approved
Vasopressin
ANDA #214314
Vasopressin Solution; Intravenous ORIG-1 Eugia Pharma Approved

August 12, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aprepitant
ANDA #211835
Aprepitant Capsule; Oral SUPPL-1 Torrent Labeling Approved
Aprepitant
ANDA #211835
Aprepitant Capsule; Oral SUPPL-1 Torrent Labeling Approved
Capecitabine
ANDA #200483
Capecitabine Tablet; Oral SUPPL-7 Hikma Labeling Approved
Cetrorelix Acetate
ANDA #215737
Cetrorelix Acetate Powder; Subcutaneous ORIG-1 Akorn Approved
Granisetron Hydrochloride
ANDA #077842
Granisetron Hydrochloride Tablet; Oral SUPPL-14 Hikma Labeling Approved
Granisetron Hydrochloride
ANDA #078080
Granisetron Hydrochloride Tablet; Oral SUPPL-8 Teva Pharms Labeling Approved
Isopto Atropine
NDA #208151
Atropine Sulfate Solution/Drops; Ophthalmic SUPPL-3 Alcon Labs Inc Manufacturing (CMC) Approved
Lisdexamfetamine Dimesylate
ANDA #202802
Lisdexamfetamine Dimesylate Capsule; Oral ORIG-1 Actavis Elizabeth Tentative Approval
Mirena
NDA #021225
Levonorgestrel Intrauterine Device; Intrauterine SUPPL-43 Bayer Hlthcare Efficacy Approved
Precedex
NDA #021038
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-31 Hospira Labeling Approved
Precedex
NDA #021038
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-33 Hospira Labeling Approved

August 11, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Brexpiprazole
ANDA #213692
Brexpiprazole Tablet; Oral ORIG-1 Teva Pharms Usa Inc Approved
Enhertu
BLA #761139
Fam-Trastuzumab Deruxtecan-Nxki Injectable; Injection SUPPL-21 Daiichi Sankyo Efficacy Approved
Meclizine Hydrochloride
ANDA #203003
Meclizine Hydrochloride Tablet; Oral ORIG-1 Lupin Ltd Approved
Memantine Hydrochloride
ANDA #214731
Memantine Hydrochloride Capsule, Extended Release; Oral ORIG-1 Novast Labs Ltd Tentative Approval
Nifedipine
ANDA #210012
Nifedipine Tablet, Extended Release; Oral SUPPL-3 Zydus Pharms Labeling Approved
Nifedipine
ANDA #210012
Nifedipine Tablet, Extended Release; Oral SUPPL-3 Zydus Pharms Labeling Approved
Nisoldipine
ANDA #079051
Nisoldipine Tablet, Extended Release; Oral SUPPL-5 Mylan Labeling Approved
Nisoldipine
ANDA #091001
Nisoldipine Tablet, Extended Release; Oral SUPPL-5 Mylan Labeling Approved
Nitazoxanide
ANDA #213820
Nitazoxanide Tablet; Oral SUPPL-2 Rising Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-25 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-20 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-23 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-25 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-26 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-20 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-21 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-23 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-25 Teva Labeling Approved
Pantoprazole Sodium
ANDA #077056
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-26 Teva Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-26 Torrent Pharms Labeling Approved
Pirfenidone
ANDA #212759
Pirfenidone Tablet; Oral SUPPL-1 Teva Pharms Usa Labeling Approved
Pirfenidone
ANDA #212759
Pirfenidone Tablet; Oral SUPPL-1 Teva Pharms Usa Labeling Approved
Qutenza
NDA #022395
Capsaicin Patch; Topical SUPPL-21 Averitas Labeling Approved
Tadalafil
ANDA #210608
Tadalafil Tablet; Oral ORIG-1 Prinston Inc Approved
Tadalafil
ANDA #210609
Tadalafil Tablet; Oral ORIG-1 Prinston Inc Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-9 Genentech Inc Efficacy Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-5 Genentech Inc Efficacy Approved
Xofluza
NDA #214410
Baloxavir Marboxil For Suspension; Oral ORIG-2 Genentech Inc Efficacy Approved

August 10, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ampicillin Sodium
ANDA #090583
Ampicillin Sodium Injectable; Injection SUPPL-3 Sagent Pharms Inc Labeling Approved
Cellcept
NDA #050722
Mycophenolate Mofetil Capsule; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050722
Mycophenolate Mofetil Capsule; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050723
Mycophenolate Mofetil Tablet; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050723
Mycophenolate Mofetil Tablet; Oral SUPPL-50 Roche Palo Labeling Approved
Cellcept
NDA #050758
Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-48 Roche Palo Labeling Approved
Cellcept
NDA #050758
Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-48 Roche Palo Labeling Approved
Cellcept
NDA #050759
Mycophenolate Mofetil For Suspension; Oral SUPPL-55 Roche Palo Labeling Approved
Cellcept
NDA #050759
Mycophenolate Mofetil For Suspension; Oral SUPPL-55 Roche Palo Labeling Approved
Cromolyn Sodium
ANDA #075437
Cromolyn Sodium Solution; Inhalation SUPPL-1 Fera Pharms Llc Manufacturing (CMC) Approved
Cromolyn Sodium
ANDA #075437
Cromolyn Sodium Solution; Inhalation SUPPL-1 Fera Pharms Llc Manufacturing (CMC) Approved
Estradiol
ANDA #211783
Estradiol Gel; Transdermal ORIG-1 Chemo Research Sl Approved
Levofloxacin
ANDA #076710
Levofloxacin Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Levofloxacin
ANDA #076710
Levofloxacin Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Lidocaine and Prilocaine
ANDA #213923
Lidocaine; Prilocaine Cream; Topical SUPPL-1 Aleor Dermaceuticals Manufacturing (CMC) Approved
Tabrecta
NDA #213591
Capmatinib Hydrochloride Tablet; Oral SUPPL-4 Novartis Pharm Efficacy Approved
Trabectedin
ANDA #214837
Trabectedin Injectable; Injection ORIG-1 Natco Pharma Ltd Tentative Approval
Vasopressin
ANDA #212945
Vasopressin Injectable; Injection ORIG-1 Amneal Eu Ltd Tentative Approval

August 9, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bupropion Hydrochloride
ANDA #202304
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Prinston Inc Labeling Approved
Bupropion Hydrochloride
ANDA #202304
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Prinston Inc Labeling Approved
Carboprost Tromethamine
ANDA #214499
Carboprost Tromethamine Injectable; Injection ORIG-1 Long Grove Pharms Approved
Cefepime Hydrochloride
ANDA #212721
Cefepime Hydrochloride Injectable; Injection SUPPL-3 Astral Labeling Approved
Empagliflozin; Linagliptin
ANDA #212366
Empagliflozin;Linagliptin Tablet; Oral ORIG-1 Alkem Labs Ltd Tentative Approval
Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #076766
Fluconazole Injectable; Injection SUPPL-10 Baxter Hlthcare Labeling Approved
Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #076766
Fluconazole Injectable; Injection SUPPL-12 Baxter Hlthcare Labeling Approved
Glycerol Phenylbutyrate
ANDA #215139
Glycerol Phenylbutyrate Liquid; Oral ORIG-1 Annora Pharma Tentative Approval
Lorazepam
ANDA #076150
Lorazepam Injectable; Injection SUPPL-5 Intl Medication Sys Labeling Approved
Venlafaxine Hydrochloride
ANDA #209193
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Dexcel Pharma Labeling Approved

August 8, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Allopurinol
ANDA #212363
Allopurinol Injectable; Injection SUPPL-2 Gland Pharma Ltd Labeling Approved
Daptomycin
NDA #210282
Daptomycin Powder; Intravenous SUPPL-1 Hospira Inc Labeling Approved
Dexamethasone
ANDA #215604
Dexamethasone Tablet; Oral ORIG-1 Novitium Pharma Approved
Diltiazem Hydrochloride
ANDA #216304
Diltiazem Hydrochloride Capsule, Extended Release; Oral ORIG-1 Amta Approved
Labetalol Hydrochloride
ANDA #212719
Labetalol Hydrochloride Tablet; Oral ORIG-1 Unichem Approved
Midazolam
NDA #216359
Midazolam Injectable; Autoinjector ORIG-1 Rafa Labs Ltd Type 5 - New Formulation or New Manufacturer Approved
Prochlorperazine Maleate
ANDA #216495
Prochlorperazine Maleate Tablet; Oral ORIG-1 Zydus Approved
Vigadrone
ANDA #210196
Vigabatrin For Solution; Oral SUPPL-2 Aucta Labeling Approved
Vigadrone
ANDA #210196
Vigabatrin For Solution; Oral SUPPL-4 Aucta Labeling Approved
Vigadrone
ANDA #210196
Vigabatrin For Solution; Oral SUPPL-6 Aucta Labeling Approved
Vigadrone
ANDA #210196
Vigabatrin For Solution; Oral SUPPL-12 Aucta Labeling Approved

August 5, 2022

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aspirin and Dipyridamole
ANDA #078804
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-10 Barr Labeling Approved
Aspirin and Dipyridamole
ANDA #078804
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-10 Barr Labeling Approved
Clindamycin Phosphate
ANDA #214668
Clindamycin Phosphate Gel; Topical ORIG-1 Amneal Approved
Darunavir
ANDA #206288
Darunavir Tablet; Oral ORIG-1 Cipla Ltd Tentative Approval
Enhertu
BLA #761139
Fam-Trastuzumab Deruxtecan-Nxki Injectable; Injection SUPPL-22 Daiichi Sankyo Efficacy Approved
Haloette
ANDA #211328
Ethinyl Estradiol; Etonogestrel Ring; Vaginal ORIG-1 Mayne Pharma Approved
Keytruda
BLA #125514
Pembrolizumab Solution; Intravenous SUPPL-133 Merck Sharp Dohme Labeling Approved
Keytruda
BLA #125514
Pembrolizumab Solution; Intravenous SUPPL-133 Merck Sharp Dohme Labeling Approved
Lenvima
NDA #206947
Lenvatinib Mesylate Capsule; Oral SUPPL-25 Eisai Inc Labeling Approved
Lenvima
NDA #206947
Lenvatinib Mesylate Capsule; Oral SUPPL-25 Eisai Inc Labeling Approved
Levetiracetam
ANDA #090601
Levetiracetam Solution; Oral SUPPL-5 Akorn Labeling Approved
Levetiracetam
ANDA #090601
Levetiracetam Solution; Oral SUPPL-10 Akorn Labeling Approved
Levetiracetam
ANDA #090601
Levetiracetam Solution; Oral SUPPL-5 Akorn Labeling Approved
Levetiracetam
ANDA #090601
Levetiracetam Solution; Oral SUPPL-6 Akorn Labeling Approved
Levetiracetam
ANDA #090601
Levetiracetam Solution; Oral SUPPL-10 Akorn Labeling Approved
Levolet
NDA #021137
Levothyroxine Sodium Tablet; Oral SUPPL-5 Genus Lifesciences Efficacy Approved
Myfembree
NDA #214846
Estradiol; Norethindrone Acetate; Relugolix Tablet; Oral SUPPL-2 Myovant Sciences Efficacy Approved
Nubeqa
NDA #212099
Darolutamide Tablet; Oral SUPPL-2 Bayer Healthcare Efficacy Approved
Vasopressin
ANDA #212944
Vasopressin Solution; Intravenous ORIG-1 Amneal Approved
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