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 |