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.
June 8, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
NDA #208216 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-6 | Actavis Llc | Labeling | Approved |
June 7, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium
ANDA #203824 |
Amoxicillin; Clavulanate Potassium | Tablet; Oral | SUPPL-13 | Hikma Pharms | Labeling | Approved |
| Bendamustine Hydrochloride
ANDA #206554 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Nang Kuang Pharm Co | Approved | |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-26 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-27 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-26 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-27 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-53 | Actavis Elizabeth | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-53 | Actavis Elizabeth | Labeling | Approved |
| Cyclophosphamide
NDA #210852 |
Cyclophosphamide | Vial; Intravenous | ORIG-1 | Dr Reddys Labs Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Darunavir
ANDA #214085 |
Darunavir | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Dexmedetomidine Hydrochloride
ANDA #217308 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Milla Pharms | Approved | |
| Draximage Dtpa
NDA #018511 |
Technetium Tc-99m Pentetate Kit | Injectable; Injection | SUPPL-32 | Jubilant | Labeling | Approved |
| Droxia
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-57 | Cheplapharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #206055 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Hydrea
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-57 | Cheplapharm | Labeling | Approved |
| Medroxyprogesterone Acetate
ANDA #215397 |
Medroxyprogesterone Acetate | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Ticagrelor
ANDA #216187 |
Ticagrelor | Tablet; Oral | ORIG-1 | Changzhou Pharm | Tentative Approval | |
| Veklury
NDA #214787 |
Remdesivir | Powder; Intravenous | SUPPL-23 | Gilead Sciences Inc | Labeling | Approved |
| Veklury
NDA #214787 |
Remdesivir | Solution; Intravenous | SUPPL-23 | Gilead Sciences Inc | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208209 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-1 | Accord Hlthcare | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208209 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-1 | Accord Hlthcare | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
June 6, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #203434 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-3 | Novast Labs | Labeling | Approved |
| Acetazolamide
ANDA #204691 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-9 | Nostrum Labs Inc | Labeling | Approved |
| Acetazolamide
ANDA #204691 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-9 | Nostrum Labs Inc | Labeling | Approved |
| Alendronate Sodium
ANDA #090124 |
Alendronate Sodium | Tablet; Oral | SUPPL-16 | Aurobindo Pharma | Labeling | Approved |
| Alendronate Sodium
ANDA #090124 |
Alendronate Sodium | Tablet; Oral | SUPPL-16 | Aurobindo Pharma | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203326 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-30 | Hikma | Labeling | Approved |
| Cefdinir
ANDA #065332 |
Cefdinir | For Suspension; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Cefdinir
ANDA #065332 |
Cefdinir | For Suspension; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Dapsone
ANDA #213907 |
Dapsone | Gel; Topical | ORIG-1 | Acrux Dds | Approved | |
| Enoxaparin Sodium (Preservative Free)
ANDA #214646 |
Enoxaparin Sodium | Injectable; Subcutaneous | ORIG-1 | Be Pharms | Approved | |
| Heparin Sodium
ANDA #214804 |
Heparin Sodium | Injectable; Injection | SUPPL-2 | Be Pharms | Labeling | Approved |
| Ketoconazole
ANDA #075912 |
Ketoconazole | Tablet; Oral | SUPPL-15 | Senores Pharms | Labeling | Approved |
| Ketoconazole
ANDA #075912 |
Ketoconazole | Tablet; Oral | SUPPL-15 | Senores Pharms | Labeling | Approved |
| Ketoconazole
ANDA #075912 |
Ketoconazole | Tablet; Oral | SUPPL-15 | Senores Pharms | Labeling | Approved |
| Ketoconazole
ANDA #210457 |
Ketoconazole | Tablet; Oral | SUPPL-2 | Strides Pharma | Labeling | Approved |
| Ketoconazole
ANDA #210457 |
Ketoconazole | Tablet; Oral | SUPPL-2 | Strides Pharma | Labeling | Approved |
| Mesalamine
ANDA #217533 |
Mesalamine | Capsule, Extended Release; Oral | ORIG-1 | Amta | Approved | |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-13 | Strides Pharma | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-13 | Strides Pharma | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-1 | Dr Reddys | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-2 | Dr Reddys | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-4 | Dr Reddys | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-2 | Dr Reddys | Labeling | Approved |
| Renvela
NDA #022127 |
Sevelamer Carbonate | Tablet; Oral | SUPPL-21 | Sanofi | Labeling | Approved |
| Renvela
NDA #022127 |
Sevelamer Carbonate | Tablet; Oral | SUPPL-21 | Sanofi | Labeling | Approved |
| Roflumilast
ANDA #208299 |
Roflumilast | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Roflumilast
ANDA #208299 |
Roflumilast | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Roflumilast
ANDA #208299 |
Roflumilast | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Solifenacin Succinate
ANDA #211622 |
Solifenacin Succinate | Tablet; Oral | ORIG-1 | Lannett Co Inc | Approved | |
| Sumatriptan Succinate
ANDA #090358 |
Sumatriptan Succinate | Injectable; Subcutaneous | SUPPL-29 | Sun Pharm | Labeling | Approved |
| Sumatriptan Succinate
ANDA #090358 |
Sumatriptan Succinate | Injectable; Subcutaneous | SUPPL-29 | Sun Pharm | Labeling | Approved |
| Tadalafil
ANDA #212515 |
Tadalafil | Tablet; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-42 | Actelion | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #205694 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-11 | Gland Pharma Ltd | Manufacturing (CMC) | Approved |
| Vancomycin Hydrochloride
ANDA #205694 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-11 | Gland Pharma Ltd | Manufacturing (CMC) | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-10 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-11 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-10 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-11 | Mylan | Labeling | Approved |
June 5, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bendamustine Hydrochloride
ANDA #204230 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Apotex | Approved | |
| Bendamustine Hydrochloride
ANDA #211001 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Kindos | Approved | |
| Bendamustine Hydrochloride
ANDA #214739 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Eugia Pharma | Approved | |
| Buprenorphine Hydrochloride
ANDA #201760 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-33 | Sun Pharm | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201760 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-33 | Sun Pharm | Labeling | Approved |
| Definity
NDA #021064 |
Perflutren | Injectable; Intravenous | SUPPL-32 | Lantheus Medcl | Labeling | Approved |
| Definity Rt
NDA #021064 |
Perflutren | Injectable; Intravenous | SUPPL-32 | Lantheus Medcl | Labeling | Approved |
| Desipramine Hydrochloride
ANDA #208105 |
Desipramine Hydrochloride | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
| Desipramine Hydrochloride
ANDA #208105 |
Desipramine Hydrochloride | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
| Desipramine Hydrochloride
ANDA #208105 |
Desipramine Hydrochloride | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container
NDA #020163 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-30 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container
NDA #020163 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-30 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container
NDA #020163 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-30 | Baxter Hlthcare | Labeling | Approved |
| Foscarnet Sodium
ANDA #213807 |
Foscarnet Sodium | Injectable; Injection | ORIG-1 | Avet Lifesciences | Approved | |
| Oriahnn (Copackaged)
NDA #213388 |
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | Capsule; Oral | SUPPL-3 | Abbvie | Labeling | Approved |
| Oriahnn (Copackaged)
NDA #213388 |
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | Capsule; Oral | SUPPL-3 | Abbvie | Labeling | Approved |
| Orilissa
NDA #210450 |
Elagolix Sodium | Tablet; Oral | SUPPL-9 | Abbvie | Labeling | Approved |
| Orilissa
NDA #210450 |
Elagolix Sodium | Tablet; Oral | SUPPL-9 | Abbvie | Labeling | Approved |
| Paclitaxel
ANDA #076131 |
Paclitaxel | Injectable; Injection | SUPPL-30 | Hospira | Manufacturing (CMC) | Approved |
| Prevymis
NDA #209939 |
Letermovir | Tablet; Oral | SUPPL-12 | Merck Sharp Dohme | Efficacy | Approved |
| Prevymis
NDA #209940 |
Letermovir | Solution; Intravenous | SUPPL-11 | Merck Sharp Dohme | Efficacy | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-19 | Accord Hlthcare | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-20 | Accord Hlthcare | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-21 | Accord Hlthcare | Labeling | Approved |
| Spy Agent Green Kit
NDA #211580 |
Indocyanine Green | Powder; Intravenous, Interstitial | SUPPL-6 | Novadaq Tech | Efficacy | Approved |
| Zoledronic Acid
ANDA #213371 |
Zoledronic Acid | Injectable; Intravenous | ORIG-1 | Hong Kong | Approved |
June 2, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adbry
BLA #761180 |
Tralokinumab | Injectable; Injection | SUPPL-5 | Leo Pharma As | Labeling | Approved |
| Anoro Ellipta
NDA #203975 |
Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-15 | Glaxosmithkline | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201066 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-22 | Mylan | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201066 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-22 | Mylan | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-30 | Sun Pharm | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-30 | Sun Pharm | Labeling | Approved |
| Ciprofloxacin Hydrochloride
ANDA #077689 |
Ciprofloxacin Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-2 | Rising | Labeling | Approved |
| Dorzolamide Hydrochloride and Timolol Maleate
ANDA #207630 |
Dorzolamide Hydrochloride; Timolol Maleate | Solution/Drops; Ophthalmic | SUPPL-1 | Eugia Pharma | Manufacturing (CMC) | Approved |
| Eplerenone
ANDA #213812 |
Eplerenone | Tablet; Oral | ORIG-1 | Annora Pharma | Approved | |
| Lampit
NDA #213464 |
Nifurtimox | Tablet; Oral | SUPPL-5 | Bayer Healthcare | Efficacy | Approved |
| Larin 1/20
ANDA #202995 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | SUPPL-2 | Novast Labs | Labeling | Approved |
| Larin 1/20
ANDA #202995 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | SUPPL-9 | Novast Labs | Labeling | Approved |
| Larin 1/20
ANDA #202995 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | SUPPL-10 | Novast Labs | Labeling | Approved |
| Minocycline
ANDA #214934 |
Minocycline | Vial; Single-Use | ORIG-1 | Nexus Pharms | Tentative Approval | |
| Nadolol
ANDA #211763 |
Nadolol | Tablet; Oral | ORIG-1 | Alembic | Approved | |
| Naloxone Hydrochloride
ANDA #213279 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-3 | Eugia Pharma | Labeling | Approved |
| Naloxone Hydrochloride
ANDA #213279 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-5 | Eugia Pharma | Labeling | Approved |
| Nelarabine
ANDA #215057 |
Nelarabine | Injectable; Intravenous | ORIG-1 | Nexus Pharms | Approved | |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137 |
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-6 | Par Pharm Inc | Labeling | Approved |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137 |
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-6 | Par Pharm Inc | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-28 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-30 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-32 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-42 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-28 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-30 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-32 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-42 | Dr Reddys Labs Ltd | Labeling | Approved |
| Pitavastatin Calcium
ANDA #206015 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-6 | Aurobindo Pharma | Labeling | Approved |
| Pitavastatin Calcium
ANDA #206015 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-7 | Aurobindo Pharma | Labeling | Approved |
| Rabeprazole Sodium
ANDA #208644 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rabeprazole Sodium
ANDA #208644 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rabeprazole Sodium
ANDA #208644 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rifaximin
ANDA #214369 |
Rifaximin | Tablet; Oral | ORIG-1 | Norwich Pharmaceuticals Inc | Tentative Approval | |
| Tacrolimus
ANDA #200744 |
Tacrolimus | Ointment; Topical | SUPPL-11 | Fougera Pharms Inc | Labeling | Approved |
| Ticagrelor
ANDA #217328 |
Ticagrelor | Tablet; Oral | ORIG-1 | Annora Pharma | Tentative Approval | |
| Trelegy Ellipta
NDA #209482 |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-18 | Glaxosmithkline | Labeling | Approved |
June 1, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arikayce Kit
NDA #207356 |
Amikacin Sulfate | Suspension, Liposomal; Inhalation | SUPPL-13 | Insmed Inc | Labeling | Approved |
| Arikayce Kit
NDA #207356 |
Amikacin Sulfate | Suspension, Liposomal; Inhalation | SUPPL-13 | Insmed Inc | Labeling | Approved |
| Bendamustine Hydrochloride
ANDA #214576 |
Bendamustine Hydrochloride | Injectable; Injection | ORIG-1 | Eugia Pharma Speclts | Tentative Approval | |
| Dicyclomine Hydrochloride
ANDA #216782 |
Dicyclomine Hydrochloride | Tablet; Oral | ORIG-1 | Twi Pharms | Approved | |
| Mycophenolate Mofetil Hydrochloride
ANDA #214283 |
Mycophenolate Mofetil Hydrochloride | Injectable; Injection | ORIG-1 | Bpi Labs | Approved | |
| Olmesartan Medoxomil and Hydrochlorothiazide
ANDA #204801 |
Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Pregabalin
ANDA #214496 |
Pregabalin | Tablet, Extended Release; Oral | ORIG-1 | Sinotherapeutics Inc | Approved |
June 8, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
NDA #208216 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-6 | Actavis Llc | Labeling | Approved |
June 7, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium
ANDA #203824 |
Amoxicillin; Clavulanate Potassium | Tablet; Oral | SUPPL-13 | Hikma Pharms | Labeling | Approved |
| Bendamustine Hydrochloride
ANDA #206554 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Nang Kuang Pharm Co | Approved | |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-26 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-27 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-26 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #090360 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-27 | Barr | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-53 | Actavis Elizabeth | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-53 | Actavis Elizabeth | Labeling | Approved |
| Cyclophosphamide
NDA #210852 |
Cyclophosphamide | Vial; Intravenous | ORIG-1 | Dr Reddys Labs Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Darunavir
ANDA #214085 |
Darunavir | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Dexmedetomidine Hydrochloride
ANDA #217308 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Milla Pharms | Approved | |
| Draximage Dtpa
NDA #018511 |
Technetium Tc-99m Pentetate Kit | Injectable; Injection | SUPPL-32 | Jubilant | Labeling | Approved |
| Droxia
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-57 | Cheplapharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #206055 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Hydrea
NDA #016295 |
Hydroxyurea | Capsule; Oral | SUPPL-57 | Cheplapharm | Labeling | Approved |
| Medroxyprogesterone Acetate
ANDA #215397 |
Medroxyprogesterone Acetate | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Ticagrelor
ANDA #216187 |
Ticagrelor | Tablet; Oral | ORIG-1 | Changzhou Pharm | Tentative Approval | |
| Veklury
NDA #214787 |
Remdesivir | Powder; Intravenous | SUPPL-23 | Gilead Sciences Inc | Labeling | Approved |
| Veklury
NDA #214787 |
Remdesivir | Solution; Intravenous | SUPPL-23 | Gilead Sciences Inc | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208209 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-1 | Accord Hlthcare | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208209 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-1 | Accord Hlthcare | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
June 6, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #203434 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-3 | Novast Labs | Labeling | Approved |
| Acetazolamide
ANDA #204691 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-9 | Nostrum Labs Inc | Labeling | Approved |
| Acetazolamide
ANDA #204691 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-9 | Nostrum Labs Inc | Labeling | Approved |
| Alendronate Sodium
ANDA #090124 |
Alendronate Sodium | Tablet; Oral | SUPPL-16 | Aurobindo Pharma | Labeling | Approved |
| Alendronate Sodium
ANDA #090124 |
Alendronate Sodium | Tablet; Oral | SUPPL-16 | Aurobindo Pharma | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203326 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-30 | Hikma | Labeling | Approved |
| Cefdinir
ANDA #065332 |
Cefdinir | For Suspension; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Cefdinir
ANDA #065332 |
Cefdinir | For Suspension; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Dapsone
ANDA #213907 |
Dapsone | Gel; Topical | ORIG-1 | Acrux Dds | Approved | |
| Enoxaparin Sodium (Preservative Free)
ANDA #214646 |
Enoxaparin Sodium | Injectable; Subcutaneous | ORIG-1 | Be Pharms | Approved | |
| Heparin Sodium
ANDA #214804 |
Heparin Sodium | Injectable; Injection | SUPPL-2 | Be Pharms | Labeling | Approved |
| Ketoconazole
ANDA #075912 |
Ketoconazole | Tablet; Oral | SUPPL-15 | Senores Pharms | Labeling | Approved |
| Ketoconazole
ANDA #075912 |
Ketoconazole | Tablet; Oral | SUPPL-15 | Senores Pharms | Labeling | Approved |
| Ketoconazole
ANDA #075912 |
Ketoconazole | Tablet; Oral | SUPPL-15 | Senores Pharms | Labeling | Approved |
| Ketoconazole
ANDA #210457 |
Ketoconazole | Tablet; Oral | SUPPL-2 | Strides Pharma | Labeling | Approved |
| Ketoconazole
ANDA #210457 |
Ketoconazole | Tablet; Oral | SUPPL-2 | Strides Pharma | Labeling | Approved |
| Mesalamine
ANDA #217533 |
Mesalamine | Capsule, Extended Release; Oral | ORIG-1 | Amta | Approved | |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-13 | Strides Pharma | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-13 | Strides Pharma | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #090111 |
Mycophenolate Mofetil | Capsule; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-1 | Dr Reddys | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-2 | Dr Reddys | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-4 | Dr Reddys | Labeling | Approved |
| Nitroglycerin
ANDA #208191 |
Nitroglycerin | Tablet; Sublingual | SUPPL-2 | Dr Reddys | Labeling | Approved |
| Renvela
NDA #022127 |
Sevelamer Carbonate | Tablet; Oral | SUPPL-21 | Sanofi | Labeling | Approved |
| Renvela
NDA #022127 |
Sevelamer Carbonate | Tablet; Oral | SUPPL-21 | Sanofi | Labeling | Approved |
| Roflumilast
ANDA #208299 |
Roflumilast | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Roflumilast
ANDA #208299 |
Roflumilast | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Roflumilast
ANDA #208299 |
Roflumilast | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Solifenacin Succinate
ANDA #211622 |
Solifenacin Succinate | Tablet; Oral | ORIG-1 | Lannett Co Inc | Approved | |
| Sumatriptan Succinate
ANDA #090358 |
Sumatriptan Succinate | Injectable; Subcutaneous | SUPPL-29 | Sun Pharm | Labeling | Approved |
| Sumatriptan Succinate
ANDA #090358 |
Sumatriptan Succinate | Injectable; Subcutaneous | SUPPL-29 | Sun Pharm | Labeling | Approved |
| Tadalafil
ANDA #212515 |
Tadalafil | Tablet; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-42 | Actelion | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #205694 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-11 | Gland Pharma Ltd | Manufacturing (CMC) | Approved |
| Vancomycin Hydrochloride
ANDA #205694 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-11 | Gland Pharma Ltd | Manufacturing (CMC) | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-10 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-11 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-10 | Mylan | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #078789 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-11 | Mylan | Labeling | Approved |
June 5, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bendamustine Hydrochloride
ANDA #204230 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Apotex | Approved | |
| Bendamustine Hydrochloride
ANDA #211001 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Kindos | Approved | |
| Bendamustine Hydrochloride
ANDA #214739 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Eugia Pharma | Approved | |
| Buprenorphine Hydrochloride
ANDA #201760 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-33 | Sun Pharm | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201760 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-33 | Sun Pharm | Labeling | Approved |
| Definity
NDA #021064 |
Perflutren | Injectable; Intravenous | SUPPL-32 | Lantheus Medcl | Labeling | Approved |
| Definity Rt
NDA #021064 |
Perflutren | Injectable; Intravenous | SUPPL-32 | Lantheus Medcl | Labeling | Approved |
| Desipramine Hydrochloride
ANDA #208105 |
Desipramine Hydrochloride | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
| Desipramine Hydrochloride
ANDA #208105 |
Desipramine Hydrochloride | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
| Desipramine Hydrochloride
ANDA #208105 |
Desipramine Hydrochloride | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container
NDA #020183 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-29 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container
NDA #020163 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-30 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container
NDA #020163 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-30 | Baxter Hlthcare | Labeling | Approved |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container
NDA #020163 |
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate | Solution; Intraperitoneal | SUPPL-30 | Baxter Hlthcare | Labeling | Approved |
| Foscarnet Sodium
ANDA #213807 |
Foscarnet Sodium | Injectable; Injection | ORIG-1 | Avet Lifesciences | Approved | |
| Oriahnn (Copackaged)
NDA #213388 |
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | Capsule; Oral | SUPPL-3 | Abbvie | Labeling | Approved |
| Oriahnn (Copackaged)
NDA #213388 |
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | Capsule; Oral | SUPPL-3 | Abbvie | Labeling | Approved |
| Orilissa
NDA #210450 |
Elagolix Sodium | Tablet; Oral | SUPPL-9 | Abbvie | Labeling | Approved |
| Orilissa
NDA #210450 |
Elagolix Sodium | Tablet; Oral | SUPPL-9 | Abbvie | Labeling | Approved |
| Paclitaxel
ANDA #076131 |
Paclitaxel | Injectable; Injection | SUPPL-30 | Hospira | Manufacturing (CMC) | Approved |
| Prevymis
NDA #209939 |
Letermovir | Tablet; Oral | SUPPL-12 | Merck Sharp Dohme | Efficacy | Approved |
| Prevymis
NDA #209940 |
Letermovir | Solution; Intravenous | SUPPL-11 | Merck Sharp Dohme | Efficacy | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-19 | Accord Hlthcare | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-20 | Accord Hlthcare | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202152 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-21 | Accord Hlthcare | Labeling | Approved |
| Spy Agent Green Kit
NDA #211580 |
Indocyanine Green | Powder; Intravenous, Interstitial | SUPPL-6 | Novadaq Tech | Efficacy | Approved |
| Zoledronic Acid
ANDA #213371 |
Zoledronic Acid | Injectable; Intravenous | ORIG-1 | Hong Kong | Approved |
June 2, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adbry
BLA #761180 |
Tralokinumab | Injectable; Injection | SUPPL-5 | Leo Pharma As | Labeling | Approved |
| Anoro Ellipta
NDA #203975 |
Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-15 | Glaxosmithkline | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201066 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-22 | Mylan | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201066 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-22 | Mylan | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-30 | Sun Pharm | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-30 | Sun Pharm | Labeling | Approved |
| Ciprofloxacin Hydrochloride
ANDA #077689 |
Ciprofloxacin Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-2 | Rising | Labeling | Approved |
| Dorzolamide Hydrochloride and Timolol Maleate
ANDA #207630 |
Dorzolamide Hydrochloride; Timolol Maleate | Solution/Drops; Ophthalmic | SUPPL-1 | Eugia Pharma | Manufacturing (CMC) | Approved |
| Eplerenone
ANDA #213812 |
Eplerenone | Tablet; Oral | ORIG-1 | Annora Pharma | Approved | |
| Lampit
NDA #213464 |
Nifurtimox | Tablet; Oral | SUPPL-5 | Bayer Healthcare | Efficacy | Approved |
| Larin 1/20
ANDA #202995 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | SUPPL-2 | Novast Labs | Labeling | Approved |
| Larin 1/20
ANDA #202995 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | SUPPL-9 | Novast Labs | Labeling | Approved |
| Larin 1/20
ANDA #202995 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | SUPPL-10 | Novast Labs | Labeling | Approved |
| Minocycline
ANDA #214934 |
Minocycline | Vial; Single-Use | ORIG-1 | Nexus Pharms | Tentative Approval | |
| Nadolol
ANDA #211763 |
Nadolol | Tablet; Oral | ORIG-1 | Alembic | Approved | |
| Naloxone Hydrochloride
ANDA #213279 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-3 | Eugia Pharma | Labeling | Approved |
| Naloxone Hydrochloride
ANDA #213279 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-5 | Eugia Pharma | Labeling | Approved |
| Nelarabine
ANDA #215057 |
Nelarabine | Injectable; Intravenous | ORIG-1 | Nexus Pharms | Approved | |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137 |
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-6 | Par Pharm Inc | Labeling | Approved |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137 |
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-6 | Par Pharm Inc | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-28 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-30 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-32 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-42 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-28 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-30 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-32 | Dr Reddys Labs Ltd | Labeling | Approved |
| Omeprazole Magnesium
ANDA #078878 |
Omeprazole Magnesium | Capsule, Delayed Release; Oral | SUPPL-42 | Dr Reddys Labs Ltd | Labeling | Approved |
| Pitavastatin Calcium
ANDA #206015 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-6 | Aurobindo Pharma | Labeling | Approved |
| Pitavastatin Calcium
ANDA #206015 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-7 | Aurobindo Pharma | Labeling | Approved |
| Rabeprazole Sodium
ANDA #208644 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rabeprazole Sodium
ANDA #208644 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rabeprazole Sodium
ANDA #208644 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rifaximin
ANDA #214369 |
Rifaximin | Tablet; Oral | ORIG-1 | Norwich Pharmaceuticals Inc | Tentative Approval | |
| Tacrolimus
ANDA #200744 |
Tacrolimus | Ointment; Topical | SUPPL-11 | Fougera Pharms Inc | Labeling | Approved |
| Ticagrelor
ANDA #217328 |
Ticagrelor | Tablet; Oral | ORIG-1 | Annora Pharma | Tentative Approval | |
| Trelegy Ellipta
NDA #209482 |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-18 | Glaxosmithkline | Labeling | Approved |
June 1, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arikayce Kit
NDA #207356 |
Amikacin Sulfate | Suspension, Liposomal; Inhalation | SUPPL-13 | Insmed Inc | Labeling | Approved |
| Arikayce Kit
NDA #207356 |
Amikacin Sulfate | Suspension, Liposomal; Inhalation | SUPPL-13 | Insmed Inc | Labeling | Approved |
| Bendamustine Hydrochloride
ANDA #214576 |
Bendamustine Hydrochloride | Injectable; Injection | ORIG-1 | Eugia Pharma Speclts | Tentative Approval | |
| Dicyclomine Hydrochloride
ANDA #216782 |
Dicyclomine Hydrochloride | Tablet; Oral | ORIG-1 | Twi Pharms | Approved | |
| Mycophenolate Mofetil Hydrochloride
ANDA #214283 |
Mycophenolate Mofetil Hydrochloride | Injectable; Injection | ORIG-1 | Bpi Labs | Approved | |
| Olmesartan Medoxomil and Hydrochlorothiazide
ANDA #204801 |
Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Pregabalin
ANDA #214496 |
Pregabalin | Tablet, Extended Release; Oral | ORIG-1 | Sinotherapeutics Inc | Approved |
May 31, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride
ANDA #216800 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Annora Pharma | Approved | |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-13 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-20 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-2 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-5 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-9 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-13 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-18 | Hec Pharm | Labeling | Approved |
| Clarithromycin
ANDA #203584 |
Clarithromycin | Tablet; Oral | SUPPL-20 | Hec Pharm | Labeling | Approved |
| Claritin
NDA #021952 |
Loratadine | Capsule; Oral | SUPPL-22 | Bayer Healthcare Llc | Labeling | Approved |
| Cotellic
NDA #206192 |
Cobimetinib Fumarate | Tablet; Oral | SUPPL-6 | Genentech Inc | Labeling | Approved |
| Dapsone
ANDA #212701 |
Dapsone | Gel; Topical | ORIG-1 | Amneal | Approved | |
| Gefitinib
ANDA #212827 |
Gefitinib | Tablet; Oral | ORIG-1 | Natco | Approved | |
| Injectafer
NDA #203565 |
Ferric Carboxymaltose | Solution; Intravenous | SUPPL-20 | Am Regent | Efficacy | Approved |
| Injectafer
NDA #203565 |
Ferric Carboxymaltose | Solution; Intravenous | SUPPL-24 | Am Regent | Labeling | Approved |
| Lynparza
NDA #208558 |
Olaparib | Tablet; Oral | SUPPL-25 | Astrazeneca | Efficacy | Approved |
| Naloxone Hydrochloride
ANDA #070172 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-31 | Hospira | Labeling | Approved |
| Naproxen
ANDA #216908 |
Naproxen | Tablet, Delayed Release; Oral | ORIG-1 | Tulex Pharms Inc | Approved | |
| Pirfenidone
ANDA #212709 |
Pirfenidone | Tablet; Oral | ORIG-1 | Apotex | Approved | |
| Pramipexole Dihydrochloride
ANDA #203615 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-3 | Actavis Elizabeth | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #203615 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-3 | Actavis Elizabeth | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #204518 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alembic | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #204518 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alembic | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #204518 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alembic | Labeling | Approved |
May 30, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cisatracurium Besylate
ANDA #212190 |
Cisatracurium Besylate | Injectable; Injection | SUPPL-2 | Piramal Hlthcare Uk | Labeling | Approved |
| Cisatracurium Besylate
ANDA #212190 |
Cisatracurium Besylate | Injectable; Injection | SUPPL-4 | Piramal Hlthcare Uk | Labeling | Approved |
| Cisatracurium Besylate
ANDA #212432 |
Cisatracurium Besylate | Injectable; Injection | SUPPL-1 | Piramal Hlthcare Uk | Labeling | Approved |
| Cisatracurium Besylate
ANDA #212432 |
Cisatracurium Besylate | Injectable; Injection | SUPPL-3 | Piramal Hlthcare Uk | Labeling | Approved |
| Fintepla
NDA #212102 |
Fenfluramine Hydrochloride | Solution; Oral | SUPPL-9 | Zogenix Inc | REMS | Approved |
| Jencycla
ANDA #091323 |
Norethindrone | Tablet; Oral-28 | SUPPL-8 | Lupin Ltd | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #217442 |
Lisdexamfetamine Dimesylate | Capsule; Oral | ORIG-1 | Ascent Pharms Inc | Tentative Approval | |
| Mesalamine
ANDA #216941 |
Mesalamine | Enema; Rectal | ORIG-1 | Encube | Approved | |
| Obeticholic Acid
ANDA #214862 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Apotex | Approved | |
| Obeticholic Acid
ANDA #214980 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Lupin Ltd | Approved | |
| Obeticholic Acid
ANDA #215017 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Msn | Approved | |
| Quetiapine Fumarate
ANDA #202674 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-22 | Unichem | Labeling | Approved |
| Quetiapine Fumarate
ANDA #202674 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-22 | Unichem | Labeling | Approved |
| Semglee
BLA #761201 |
Insulin Glargine-Yfgn | Injectable; Injection | SUPPL-7 | Mylan Pharms Inc | Labeling | Approved |
| Semglee
BLA #761201 |
Insulin Glargine-Yfgn | Injectable; Injection | SUPPL-7 | Mylan Pharms Inc | Labeling | Approved |
| Semglee
BLA #761201 |
Insulin Glargine-Yfgn | Injectable; Injection | SUPPL-7 | Mylan Pharms Inc | Labeling | Approved |
| Vevye
NDA #217469 |
Cyclosporine | Solution; Ophthalmic | ORIG-1 | Novaliq Gmbh | Type 5 - New Formulation or New Manufacturer | Approved |
May 28, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albuterol Sulfate
ANDA #207857 |
Albuterol Sulfate | Solution; Inhalation | SUPPL-8 | Sun Pharm | Labeling | Approved |
| Albuterol Sulfate
ANDA #207857 |
Albuterol Sulfate | Solution; Inhalation | SUPPL-8 | Sun Pharm | Labeling | Approved |
| Azithromycin
ANDA #065246 |
Azithromycin | For Suspension; Oral | SUPPL-30 | Pliva | Labeling | Approved |
| Azithromycin
ANDA #065246 |
Azithromycin | For Suspension; Oral | SUPPL-30 | Pliva | Labeling | Approved |