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.
March 18, 2024
Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Sporanox
NDA #020657 |
Itraconazole | Solution; Oral | SUPPL-42 | Janssen Pharms | Labeling | Approved |
Stelara
BLA #125261 |
Ustekinumab | Injectable; Injection | SUPPL-163 | Centocor Ortho Biotech Inc | Labeling | Approved |
Stelara
BLA #761044 |
Ustekinumab | Injectable; Injection | SUPPL-13 | Janssen Biotech | Labeling | Approved |
Stelara
BLA #761044 |
Ustekinumab | Injectable; Injection | SUPPL-13 | Janssen Biotech | Labeling | Approved |
March 15, 2024
Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-9 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-6 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-9 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-10 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-6 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-9 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-10 | Amneal Pharms Ny | Labeling | Approved |
Aripiprazole
ANDA #215595 |
Aripiprazole | Solution; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
Aripiprazole
ANDA #215595 |
Aripiprazole | Solution; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
Chlorpromazine Hydrochloride
ANDA #213368 |
Chlorpromazine Hydrochloride | Tablet; Oral | SUPPL-1 | Zydus | Labeling | Approved |
Dasatinib
ANDA #202103 |
Dasatinib | Tablet; Oral | SUPPL-7 | Apotex | Labeling | Approved |
Dasatinib
ANDA #202103 |
Dasatinib | Tablet; Oral | SUPPL-7 | Apotex | Labeling | Approved |
Delsym
NDA #018658 |
Dextromethorphan Polistirex | Suspension, Extended Release; Oral | SUPPL-34 | Rb Hlth | Labeling | Approved |
Edurant
NDA #202022 |
Rilpivirine Hydrochloride | Tablet; Oral | SUPPL-20 | Janssen Prods | Efficacy | Approved |
Edurant
NDA #202022 |
Rilpivirine Hydrochloride | Tablet; Oral | SUPPL-22 | Janssen Prods | Efficacy | Approved |
Edurant
NDA #219016 |
Rilpivirine | Tablet; Oral | ORIG-1 | Janssen Prods | Type 3 - New Dosage Form | Approved |
Etodolac
ANDA #208834 |
Etodolac | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
Etodolac
ANDA #208834 |
Etodolac | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
Etodolac
ANDA #208834 |
Etodolac | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
Finasteride and Tadalafil
ANDA #218232 |
Finasteride; Tadalafil | Capsule; Oral | ORIG-1 | Zydus | Approved | |
Increlex
BLA #021839 |
Mecasermin Recombinant | Injectable; Subcutaneous | SUPPL-31 | Ipsen Inc | Efficacy | Approved |
Nicotine Polacrilex
ANDA #076775 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076775 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-35 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-35 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-30 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-35 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076779 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-36 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076779 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076779 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-36 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076789 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076789 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #078325 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-19 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078325 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-19 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078326 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078326 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078546 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078546 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-16 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078546 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078547 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078547 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078547 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078968 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-13 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078968 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-10 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078968 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-13 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091349 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-15 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091349 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-15 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091354 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-14 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091354 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-14 | Perrigo R and D | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202142 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-9 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202142 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-9 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #204407 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-10 | Novel Labs Inc | Labeling | Approved |
Sapropterin Dihydrochloride
ANDA #209452 |
Sapropterin Dihydrochloride | Powder; Oral | SUPPL-6 | Dr Reddys | Labeling | Approved |
Sapropterin Dihydrochloride
ANDA #209452 |
Sapropterin Dihydrochloride | Powder; Oral | SUPPL-6 | Dr Reddys | Labeling | Approved |
Sapropterin Dihydrochloride
ANDA #215798 |
Sapropterin Dihydrochloride | Powder; Oral | SUPPL-2 | Dr Reddys | Labeling | Approved |
Sodium Acetate
ANDA #216920 |
Sodium Acetate | Injectable; Injection | ORIG-1 | Hikma | Approved | |
Vancomycin Hydrochloride
ANDA #065478 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-2 | Pai Holdings Pharm | Labeling | Approved |
Vancomycin Hydrochloride
ANDA #065478 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-3 | Pai Holdings Pharm | Labeling | Approved |
Xhance
NDA #209022 |
Fluticasone Propionate | Spray, Metered; Nasal | SUPPL-19 | Optinose Us Inc | Efficacy | Approved |
March 14, 2024
Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Altoprev
NDA #021316 |
Lovastatin | Tablet, Extended Release; Oral | SUPPL-37 | Covis | Labeling | Approved |
Cabazitaxel Injection
NDA #207970 |
Cabazitaxel | Injectable; Injection | ORIG-1 | Actavis Llc | Type 5 - New Formulation or New Manufacturer | Approved |
Clobetasol Propionate
ANDA #208563 |
Clobetasol Propionate | Aerosol, Foam; Topical | ORIG-1 | Taro | Approved | |
Doxycycline Hyclate
ANDA #217794 |
Doxycycline Hyclate | Injectable; Injection | ORIG-1 | Lupin Ltd | Approved | |
Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-58 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Injection | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Injection | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Intravenous | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Intravenous | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Famotidine
ANDA #218461 |
Famotidine | Tablet; Oral | ORIG-1 | Graviti Pharms | Approved | |
Livalo
NDA #022363 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-22 | Kowa Co | Labeling | Approved |
Nizoral Anti-Dandruff
NDA #020310 |
Ketoconazole | Shampoo; Topical | SUPPL-32 | Kramer | Manufacturing (CMC) | Approved |
Oxycodone and Acetaminophen
ANDA #204407 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-9 | Novel Labs Inc | Labeling | Approved |
Phenylephrine Hydrochloride
ANDA #218412 |
Phenylephrine Hydrochloride | Solution; Intravenous | ORIG-1 | Hainan Poly | Approved | |
Rezdiffra
NDA #217785 |
Resmetirom | Tablet; Oral | ORIG-1 | Madrigal Pharmaceuticals Inc | Type 1 - New Molecular Entity | Approved |
Rifaximin
ANDA #214369 |
Rifaximin | Tablet; Oral | ORIG-1 | Norwich Pharmaceuticals Inc | Tentative Approval | |
Roxicet
ANDA #089351 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-36 | Hikma | Labeling | Approved |
Sunitinib Malate
ANDA #218615 |
Sunitinib Malate | Capsule; Oral | ORIG-1 | Eugia Pharma | Approved | |
Tabrecta
NDA #213591 |
Capmatinib Hydrochloride | Tablet; Oral | SUPPL-11 | Novartis Pharm | Labeling | Approved |
Temazepam
ANDA #071456 |
Temazepam | Capsule; Oral | SUPPL-15 | Novel Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-1 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-2 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-1 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-2 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-1 | Watson Labs Inc | Labeling | Approved |
Treprostinil
ANDA #203649 |
Treprostinil | Injectable; Iv (Infusion), Subcutaneous | SUPPL-10 | Sandoz | Labeling | Approved |
March 13, 2024
Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Camcevi Kit
NDA #211488 |
Leuprolide Mesylate | Emulsion; Subcutaneous | SUPPL-4 | Accord | Labeling | Approved |
Camcevi Kit
NDA #211488 |
Leuprolide Mesylate | Emulsion; Subcutaneous | SUPPL-4 | Accord | Labeling | Approved |
Chlorpromazine Hydrochloride
ANDA #217275 |
Chlorpromazine Hydrochloride | Injectable; Injection | ORIG-1 | Zydus Pharms | Approved | |
Edaravone
ANDA #218349 |
Edaravone | Injectable; Injection | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
Livmarli
NDA #214662 |
Maralixibat Chloride | Solution; Oral | SUPPL-5 | Mirum | Efficacy | Approved |
Livmarli
NDA #214662 |
Maralixibat Chloride | Solution; Oral | SUPPL-8 | Mirum | Labeling | Approved |
Metformin Hydrochloride
ANDA #211163 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
Oncaspar
BLA #103411 |
Pegaspargase | Vial | SUPPL-5207 | Sigma Tau | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040778 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-31 | Amneal Pharms Ny | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040778 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-31 | Amneal Pharms Ny | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202677 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-18 | Alvogen | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202677 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-18 | Alvogen | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207333 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Lannett Co Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207333 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Lannett Co Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-11 | Wes Pharma Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Wes Pharma Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-11 | Wes Pharma Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Wes Pharma Inc | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-12 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-13 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-14 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-15 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-12 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-13 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-14 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-15 | Actavis Totowa | Labeling | Approved |
Tevimbra
BLA #761232 |
Tislelizumab | Injection; Solution | ORIG-1 | Beigene | Type 1 - New Molecular Entity | Approved |
March 12, 2024
Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Butalbital, Acetaminophen and Caffeine
ANDA #216376 |
Acetaminophen; Butalbital; Caffeine | Capsule; Oral | ORIG-1 | Quagen | Approved | |
Elepsia Xr
NDA #204417 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-9 | Tripoint | Labeling | Approved |
Hydromorphone Hydrochloride
ANDA #205629 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-19 | Osmotica Pharm Us | Labeling | Approved |
Keppra
NDA #021035 |
Levetiracetam | Tablet; Oral | SUPPL-115 | Ucb Inc | Labeling | Approved |
Keppra
NDA #021505 |
Levetiracetam | Solution; Oral | SUPPL-53 | Ucb Inc | Labeling | Approved |
Keppra
NDA #021872 |
Levetiracetam | Injectable; Intravenous | SUPPL-35 | Ucb Inc | Labeling | Approved |
Keppra Xr
NDA #022285 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-36 | Ucb Inc | Labeling | Approved |
Levetiracetam In Sodium Chloride
NDA #202543 |
Levetiracetam | Injectable; Intravenous | SUPPL-24 | Hq Spclt Pharma | Labeling | Approved |
Metoprolol Tartrate
ANDA #078459 |
Metoprolol Tartrate | Tablet; Oral | SUPPL-15 | Ipca Labs Ltd | Labeling | Approved |
Metoprolol Tartrate
ANDA #078459 |
Metoprolol Tartrate | Tablet; Oral | SUPPL-16 | Ipca Labs Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-10 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-15 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-19 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-21 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-10 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-11 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-12 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-13 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-15 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-16 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-19 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-21 | Aurobindo Pharma Ltd | Labeling | Approved |
Onfi
NDA #202067 |
Clobazam | Tablet; Oral | SUPPL-8 | Lundbeck Pharms Llc | Labeling | Approved |
Onfi
NDA #202067 |
Clobazam | Tablet; Oral | SUPPL-8 | Lundbeck Pharms Llc | Labeling | Approved |
Onfi
NDA #203993 |
Clobazam | Suspension; Oral | SUPPL-10 | Lundbeck Pharms Llc | Labeling | Approved |
Onfi
NDA #203993 |
Clobazam | Suspension; Oral | SUPPL-10 | Lundbeck Pharms Llc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040105 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-38 | Vintage Pharms | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040105 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-38 | Vintage Pharms | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-15 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-15 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-16 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040608 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040608 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-13 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-22 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-22 | Actavis Elizabeth | Labeling | Approved |
Rosuvastatin Calcium
ANDA #207616 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-11 | Hetero Labs Ltd V | Labeling | Approved |
Rosuvastatin Calcium
ANDA #207616 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Hetero Labs Ltd V | Labeling | Approved |
Spritam
NDA #207958 |
Levetiracetam | Tablet, For Suspension; Oral | SUPPL-25 | Aprecia Pharms | Labeling | Approved |
Sympazan
NDA #210833 |
Clobazam | Film; Oral | SUPPL-6 | Otter Pharms | Labeling | Approved |
Tecfidera
NDA #204063 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-31 | Biogen Inc | Labeling | Approved |
Tecfidera
NDA #204063 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-31 | Biogen Inc | Labeling | Approved |
March 11, 2024
Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Ameluz
NDA #208081 |
Aminolevulinic Acid Hydrochloride | Gel; Topical | SUPPL-26 | Biofrontera | Manufacturing (CMC) | Approved |
Dextroamphetamine Sulfate
ANDA #205673 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-3 | Strides Pharma | Labeling | Approved |
Dextroamphetamine Sulfate
ANDA #205673 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-2 | Strides Pharma | Labeling | Approved |
Dextroamphetamine Sulfate
ANDA #205673 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-3 | Strides Pharma | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #040894 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-24 | Genus | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #040894 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-24 | Genus | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #200343 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-23 | Genus | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #200343 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-23 | Genus | Labeling | Approved |
Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-160 | Merck Sharp Dohme | Labeling | Approved |
Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-160 | Merck Sharp Dohme | Labeling | Approved |
Opill
NDA #017031 |
Norgestrel | Tablet; Oral | SUPPL-42 | Laboratoire Hra | Labeling | Approved |
Opill
NDA #017031 |
Norgestrel | Tablet; Oral | SUPPL-43 | Laboratoire Hra | Labeling | Approved |
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-17 | Barr Labs Inc | Labeling | Approved |
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-17 | Barr Labs Inc | Labeling | Approved |
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-18 | Barr Labs Inc | Labeling | Approved |
Phenylephrine Hydrochloride
ANDA #209968 |
Phenylephrine Hydrochloride | Solution; Intravenous | SUPPL-1 | Avet Lifesciences | Labeling | Approved |
Quetiapine Fumarate
ANDA #208781 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-3 | Prinston Inc | Manufacturing (CMC) | Approved |
Quetiapine Fumarate
ANDA #208781 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-3 | Prinston Inc | Manufacturing (CMC) | Approved |
Selexipag
ANDA #216607 |
Selexipag | Injectable; Injection | ORIG-1 | Cipla Ltd | Tentative Approval |
March 18, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Sporanox
NDA #020657 |
Itraconazole | Solution; Oral | SUPPL-42 | Janssen Pharms | Labeling | Approved |
Stelara
BLA #125261 |
Ustekinumab | Injectable; Injection | SUPPL-163 | Centocor Ortho Biotech Inc | Labeling | Approved |
Stelara
BLA #761044 |
Ustekinumab | Injectable; Injection | SUPPL-13 | Janssen Biotech | Labeling | Approved |
Stelara
BLA #761044 |
Ustekinumab | Injectable; Injection | SUPPL-13 | Janssen Biotech | Labeling | Approved |
March 15, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-9 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-6 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-9 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-10 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-6 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-9 | Amneal Pharms Ny | Labeling | Approved |
Alprazolam
ANDA #078387 |
Alprazolam | Tablet, Extended Release; Oral | SUPPL-10 | Amneal Pharms Ny | Labeling | Approved |
Aripiprazole
ANDA #215595 |
Aripiprazole | Solution; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
Aripiprazole
ANDA #215595 |
Aripiprazole | Solution; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
Chlorpromazine Hydrochloride
ANDA #213368 |
Chlorpromazine Hydrochloride | Tablet; Oral | SUPPL-1 | Zydus | Labeling | Approved |
Dasatinib
ANDA #202103 |
Dasatinib | Tablet; Oral | SUPPL-7 | Apotex | Labeling | Approved |
Dasatinib
ANDA #202103 |
Dasatinib | Tablet; Oral | SUPPL-7 | Apotex | Labeling | Approved |
Delsym
NDA #018658 |
Dextromethorphan Polistirex | Suspension, Extended Release; Oral | SUPPL-34 | Rb Hlth | Labeling | Approved |
Edurant
NDA #202022 |
Rilpivirine Hydrochloride | Tablet; Oral | SUPPL-20 | Janssen Prods | Efficacy | Approved |
Edurant
NDA #202022 |
Rilpivirine Hydrochloride | Tablet; Oral | SUPPL-22 | Janssen Prods | Efficacy | Approved |
Edurant
NDA #219016 |
Rilpivirine | Tablet; Oral | ORIG-1 | Janssen Prods | Type 3 - New Dosage Form | Approved |
Etodolac
ANDA #208834 |
Etodolac | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
Etodolac
ANDA #208834 |
Etodolac | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
Etodolac
ANDA #208834 |
Etodolac | Tablet; Oral | SUPPL-7 | Amneal Pharms Co | Labeling | Approved |
Finasteride and Tadalafil
ANDA #218232 |
Finasteride; Tadalafil | Capsule; Oral | ORIG-1 | Zydus | Approved | |
Increlex
BLA #021839 |
Mecasermin Recombinant | Injectable; Subcutaneous | SUPPL-31 | Ipsen Inc | Efficacy | Approved |
Nicotine Polacrilex
ANDA #076775 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076775 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-35 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-35 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-30 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076777 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-35 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076779 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-36 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076779 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076779 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-36 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076789 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #076789 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | L Perrigo Co | Labeling | Approved |
Nicotine Polacrilex
ANDA #078325 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-19 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078325 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-19 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078326 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078326 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078546 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078546 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-16 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078546 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078547 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078547 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078547 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-20 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078968 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-13 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078968 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-10 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #078968 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-13 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091349 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-15 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091349 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-15 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091354 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-14 | Perrigo R and D | Labeling | Approved |
Nicotine Polacrilex
ANDA #091354 |
Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-14 | Perrigo R and D | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202142 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-9 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202142 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-9 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #204407 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-10 | Novel Labs Inc | Labeling | Approved |
Sapropterin Dihydrochloride
ANDA #209452 |
Sapropterin Dihydrochloride | Powder; Oral | SUPPL-6 | Dr Reddys | Labeling | Approved |
Sapropterin Dihydrochloride
ANDA #209452 |
Sapropterin Dihydrochloride | Powder; Oral | SUPPL-6 | Dr Reddys | Labeling | Approved |
Sapropterin Dihydrochloride
ANDA #215798 |
Sapropterin Dihydrochloride | Powder; Oral | SUPPL-2 | Dr Reddys | Labeling | Approved |
Sodium Acetate
ANDA #216920 |
Sodium Acetate | Injectable; Injection | ORIG-1 | Hikma | Approved | |
Vancomycin Hydrochloride
ANDA #065478 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-2 | Pai Holdings Pharm | Labeling | Approved |
Vancomycin Hydrochloride
ANDA #065478 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-3 | Pai Holdings Pharm | Labeling | Approved |
Xhance
NDA #209022 |
Fluticasone Propionate | Spray, Metered; Nasal | SUPPL-19 | Optinose Us Inc | Efficacy | Approved |
March 14, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Altoprev
NDA #021316 |
Lovastatin | Tablet, Extended Release; Oral | SUPPL-37 | Covis | Labeling | Approved |
Cabazitaxel Injection
NDA #207970 |
Cabazitaxel | Injectable; Injection | ORIG-1 | Actavis Llc | Type 5 - New Formulation or New Manufacturer | Approved |
Clobetasol Propionate
ANDA #208563 |
Clobetasol Propionate | Aerosol, Foam; Topical | ORIG-1 | Taro | Approved | |
Doxycycline Hyclate
ANDA #217794 |
Doxycycline Hyclate | Injectable; Injection | ORIG-1 | Lupin Ltd | Approved | |
Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-58 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Injection | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Injection | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Intravenous | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Entyvio
BLA #761133 |
Vedolizumab | Injectable; Intravenous | SUPPL-4 | Takeda Pharms Usa | Labeling | Approved |
Famotidine
ANDA #218461 |
Famotidine | Tablet; Oral | ORIG-1 | Graviti Pharms | Approved | |
Livalo
NDA #022363 |
Pitavastatin Calcium | Tablet; Oral | SUPPL-22 | Kowa Co | Labeling | Approved |
Nizoral Anti-Dandruff
NDA #020310 |
Ketoconazole | Shampoo; Topical | SUPPL-32 | Kramer | Manufacturing (CMC) | Approved |
Oxycodone and Acetaminophen
ANDA #204407 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-9 | Novel Labs Inc | Labeling | Approved |
Phenylephrine Hydrochloride
ANDA #218412 |
Phenylephrine Hydrochloride | Solution; Intravenous | ORIG-1 | Hainan Poly | Approved | |
Rezdiffra
NDA #217785 |
Resmetirom | Tablet; Oral | ORIG-1 | Madrigal Pharmaceuticals Inc | Type 1 - New Molecular Entity | Approved |
Rifaximin
ANDA #214369 |
Rifaximin | Tablet; Oral | ORIG-1 | Norwich Pharmaceuticals Inc | Tentative Approval | |
Roxicet
ANDA #089351 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-36 | Hikma | Labeling | Approved |
Sunitinib Malate
ANDA #218615 |
Sunitinib Malate | Capsule; Oral | ORIG-1 | Eugia Pharma | Approved | |
Tabrecta
NDA #213591 |
Capmatinib Hydrochloride | Tablet; Oral | SUPPL-11 | Novartis Pharm | Labeling | Approved |
Temazepam
ANDA #071456 |
Temazepam | Capsule; Oral | SUPPL-15 | Novel Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-1 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-2 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-1 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-2 | Watson Labs Inc | Labeling | Approved |
Ticagrelor
ANDA #208390 |
Ticagrelor | Tablet; Oral | SUPPL-1 | Watson Labs Inc | Labeling | Approved |
Treprostinil
ANDA #203649 |
Treprostinil | Injectable; Iv (Infusion), Subcutaneous | SUPPL-10 | Sandoz | Labeling | Approved |
March 13, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Camcevi Kit
NDA #211488 |
Leuprolide Mesylate | Emulsion; Subcutaneous | SUPPL-4 | Accord | Labeling | Approved |
Camcevi Kit
NDA #211488 |
Leuprolide Mesylate | Emulsion; Subcutaneous | SUPPL-4 | Accord | Labeling | Approved |
Chlorpromazine Hydrochloride
ANDA #217275 |
Chlorpromazine Hydrochloride | Injectable; Injection | ORIG-1 | Zydus Pharms | Approved | |
Edaravone
ANDA #218349 |
Edaravone | Injectable; Injection | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
Livmarli
NDA #214662 |
Maralixibat Chloride | Solution; Oral | SUPPL-5 | Mirum | Efficacy | Approved |
Livmarli
NDA #214662 |
Maralixibat Chloride | Solution; Oral | SUPPL-8 | Mirum | Labeling | Approved |
Metformin Hydrochloride
ANDA #211163 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
Oncaspar
BLA #103411 |
Pegaspargase | Vial | SUPPL-5207 | Sigma Tau | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040778 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-31 | Amneal Pharms Ny | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040778 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-31 | Amneal Pharms Ny | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202677 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-18 | Alvogen | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #202677 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-18 | Alvogen | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207333 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Lannett Co Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207333 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Lannett Co Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-11 | Wes Pharma Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Wes Pharma Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-11 | Wes Pharma Inc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Wes Pharma Inc | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-12 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-13 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-14 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-15 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-12 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-13 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-14 | Actavis Totowa | Labeling | Approved |
Pantoprazole Sodium
ANDA #090797 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-15 | Actavis Totowa | Labeling | Approved |
Tevimbra
BLA #761232 |
Tislelizumab | Injection; Solution | ORIG-1 | Beigene | Type 1 - New Molecular Entity | Approved |
March 12, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Butalbital, Acetaminophen and Caffeine
ANDA #216376 |
Acetaminophen; Butalbital; Caffeine | Capsule; Oral | ORIG-1 | Quagen | Approved | |
Elepsia Xr
NDA #204417 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-9 | Tripoint | Labeling | Approved |
Hydromorphone Hydrochloride
ANDA #205629 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-19 | Osmotica Pharm Us | Labeling | Approved |
Keppra
NDA #021035 |
Levetiracetam | Tablet; Oral | SUPPL-115 | Ucb Inc | Labeling | Approved |
Keppra
NDA #021505 |
Levetiracetam | Solution; Oral | SUPPL-53 | Ucb Inc | Labeling | Approved |
Keppra
NDA #021872 |
Levetiracetam | Injectable; Intravenous | SUPPL-35 | Ucb Inc | Labeling | Approved |
Keppra Xr
NDA #022285 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-36 | Ucb Inc | Labeling | Approved |
Levetiracetam In Sodium Chloride
NDA #202543 |
Levetiracetam | Injectable; Intravenous | SUPPL-24 | Hq Spclt Pharma | Labeling | Approved |
Metoprolol Tartrate
ANDA #078459 |
Metoprolol Tartrate | Tablet; Oral | SUPPL-15 | Ipca Labs Ltd | Labeling | Approved |
Metoprolol Tartrate
ANDA #078459 |
Metoprolol Tartrate | Tablet; Oral | SUPPL-16 | Ipca Labs Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-10 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-15 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-19 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-21 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-10 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-11 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-12 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-13 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-15 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-16 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-19 | Aurobindo Pharma Ltd | Labeling | Approved |
Olanzapine
ANDA #202050 |
Olanzapine | Tablet; Oral | SUPPL-21 | Aurobindo Pharma Ltd | Labeling | Approved |
Onfi
NDA #202067 |
Clobazam | Tablet; Oral | SUPPL-8 | Lundbeck Pharms Llc | Labeling | Approved |
Onfi
NDA #202067 |
Clobazam | Tablet; Oral | SUPPL-8 | Lundbeck Pharms Llc | Labeling | Approved |
Onfi
NDA #203993 |
Clobazam | Suspension; Oral | SUPPL-10 | Lundbeck Pharms Llc | Labeling | Approved |
Onfi
NDA #203993 |
Clobazam | Suspension; Oral | SUPPL-10 | Lundbeck Pharms Llc | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040105 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-38 | Vintage Pharms | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040105 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-38 | Vintage Pharms | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-15 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-15 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-16 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040608 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040608 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Mikart | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-13 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-22 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-21 | Actavis Elizabeth | Labeling | Approved |
Oxycodone and Acetaminophen
ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-22 | Actavis Elizabeth | Labeling | Approved |
Rosuvastatin Calcium
ANDA #207616 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-11 | Hetero Labs Ltd V | Labeling | Approved |
Rosuvastatin Calcium
ANDA #207616 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Hetero Labs Ltd V | Labeling | Approved |
Spritam
NDA #207958 |
Levetiracetam | Tablet, For Suspension; Oral | SUPPL-25 | Aprecia Pharms | Labeling | Approved |
Sympazan
NDA #210833 |
Clobazam | Film; Oral | SUPPL-6 | Otter Pharms | Labeling | Approved |
Tecfidera
NDA #204063 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-31 | Biogen Inc | Labeling | Approved |
Tecfidera
NDA #204063 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-31 | Biogen Inc | Labeling | Approved |
March 11, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Ameluz
NDA #208081 |
Aminolevulinic Acid Hydrochloride | Gel; Topical | SUPPL-26 | Biofrontera | Manufacturing (CMC) | Approved |
Dextroamphetamine Sulfate
ANDA #205673 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-3 | Strides Pharma | Labeling | Approved |
Dextroamphetamine Sulfate
ANDA #205673 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-2 | Strides Pharma | Labeling | Approved |
Dextroamphetamine Sulfate
ANDA #205673 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-3 | Strides Pharma | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #040894 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-24 | Genus | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #040894 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-24 | Genus | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #200343 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-23 | Genus | Labeling | Approved |
Hydrocodone Bitartrate and Acetaminophen
ANDA #200343 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | SUPPL-23 | Genus | Labeling | Approved |
Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-160 | Merck Sharp Dohme | Labeling | Approved |
Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-160 | Merck Sharp Dohme | Labeling | Approved |
Opill
NDA #017031 |
Norgestrel | Tablet; Oral | SUPPL-42 | Laboratoire Hra | Labeling | Approved |
Opill
NDA #017031 |
Norgestrel | Tablet; Oral | SUPPL-43 | Laboratoire Hra | Labeling | Approved |
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-17 | Barr Labs Inc | Labeling | Approved |
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-17 | Barr Labs Inc | Labeling | Approved |
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-18 | Barr Labs Inc | Labeling | Approved |
Phenylephrine Hydrochloride
ANDA #209968 |
Phenylephrine Hydrochloride | Solution; Intravenous | SUPPL-1 | Avet Lifesciences | Labeling | Approved |
Quetiapine Fumarate
ANDA #208781 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-3 | Prinston Inc | Manufacturing (CMC) | Approved |
Quetiapine Fumarate
ANDA #208781 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-3 | Prinston Inc | Manufacturing (CMC) | Approved |
Selexipag
ANDA #216607 |
Selexipag | Injectable; Injection | ORIG-1 | Cipla Ltd | Tentative Approval |
March 9, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #091215 |
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-2 | Teva Pharms Usa | Labeling | Approved |
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #091215 |
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-2 | Teva Pharms Usa | Labeling | Approved |
Indomethacin
ANDA #090403 |
Indomethacin | Capsule; Oral | SUPPL-7 | Zydus Lifesciences | Labeling | Approved |
Indomethacin
ANDA #090403 |
Indomethacin | Capsule; Oral | SUPPL-7 | Zydus Lifesciences | Labeling | Approved |
Ropivacaine Hydrochloride
ANDA #214074 |
Ropivacaine Hydrochloride | Solution; Injection | SUPPL-1 | Hikma | Labeling | Approved |
Succinylcholine Chloride
ANDA #211346 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-3 | Fresenius Kabi Usa | Labeling | Approved |
March 8, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Allopurinol
ANDA #214443 |
Allopurinol | Tablet; Oral | SUPPL-2 | Harman Finochem | Labeling | Approved |
Carbamazepine
ANDA #213159 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Apotex | Approved | |
Cisatracurium Besylate
ANDA #216538 |
Cisatracurium Besylate | Injectable; Injection | ORIG-1 | Hainan Poly | Approved | |
Dextroamphetamine Sulfate
ANDA #202893 |
Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-5 | Aurolife Pharma Llc | Labeling | Approved |
Dextroamphetamine Sulfate
ANDA #202893 |
Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-5 | Aurolife Pharma Llc | Labeling | Approved |
Dextroamphetamine Sulfate
ANDA #203548 |
Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-9 | Avanthi Inc | Labeling | Approved |
Escitalopram Oxalate
ANDA #079121 |
Escitalopram Oxalate | Solution; Oral | SUPPL-13 | Taro | Labeling | Approved |
Escitalopram Oxalate
ANDA #079121 |
Escitalopram Oxalate | Solution; Oral | SUPPL-13 | Taro | Labeling | Approved |
Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-31 | Thepharmanetwork Llc | Labeling | Approved |
Methadone Hydrochloride
ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-32 | Thepharmanetwork Llc | Labeling | Approved |
Metoclopramide
ANDA #216931 |
Metoclopramide | Spray; Nasal | ORIG-1 | Teva Pharms Inc | Tentative Approval | |
Praluent
BLA #125559 |
Alirocumab | Injectable; Injection | SUPPL-39 | Regeneron Pharmaceuticals | Efficacy | Approved |
Rifaximin
ANDA #213713 |
Rifaximin | Tablet; Oral | ORIG-1 | Sandoz Inc | Tentative Approval | |
Wegovy
NDA #215256 |
Semaglutide | Solution; Subcutaneous | SUPPL-11 | Novo | Efficacy | Approved |
March 7, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Brukinsa
NDA #213217 |
Zanubrutinib | Capsule; Oral | SUPPL-11 | Beigene | Efficacy | Approved |
Caprelsa
NDA #022405 |
Vandetanib | Tablet; Oral | SUPPL-22 | Genzyme Corp | Efficacy | Approved |
Roxicet
ANDA #087003 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-47 | Hikma | Labeling | Approved |
Talzenna
NDA #217439 |
Talazoparib | Capsule; Oral | ORIG-1 | Pfizer Inc | Type 5 - New Formulation or New Manufacturer | Approved |
March 6, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-17 | Aurolife Pharma Llc | Labeling | Approved |
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-17 | Aurolife Pharma Llc | Labeling | Approved |
Azelaic Acid
ANDA #208011 |
Azelaic Acid | Gel; Topical | SUPPL-3 | Actavis Labs Ut Inc | Labeling | Approved |
Azelaic Acid
ANDA #208011 |
Azelaic Acid | Gel; Topical | SUPPL-4 | Actavis Labs Ut Inc | Labeling | Approved |
Bavencio
BLA #761049 |
Avelumab | Injectable; Injection | SUPPL-16 | Emd Serono Inc | Labeling | Approved |
Besponsa
BLA #761040 |
Inotuzumab Ozogamicin | Powder, For Injection Solution, Lyophilized Powder | SUPPL-3 | Wyeth Pharms Inc | Efficacy | Approved |
Besponsa
BLA #761040 |
Inotuzumab Ozogamicin | Powder, For Injection Solution, Lyophilized Powder | SUPPL-3 | Wyeth Pharms Inc | Efficacy | Approved |
Bexarotene
ANDA #203174 |
Bexarotene | Capsule; Oral | SUPPL-3 | Bionpharma | Labeling | Approved |
Bydureon Bcise
NDA #209210 |
Exenatide Synthetic | Suspension, Extended Release; Subcutaneous | SUPPL-23 | Astrazeneca Ab | Labeling | Approved |
Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-15 | Accord Hlthcare | Labeling | Approved |
Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-3 | Accord Hlthcare | Labeling | Approved |
Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-7 | Accord Hlthcare | Labeling | Approved |
Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-13 | Accord Hlthcare | Labeling | Approved |
Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-14 | Accord Hlthcare | Labeling | Approved |
Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-15 | Accord Hlthcare | Labeling | Approved |
Dobutamine Hydrochloride
ANDA #074277 |
Dobutamine Hydrochloride | Injectable; Injection | SUPPL-21 | Hikma | Labeling | Approved |
Dobutamine Hydrochloride
ANDA #074277 |
Dobutamine Hydrochloride | Injectable; Injection | SUPPL-21 | Hikma | Labeling | Approved |
Empagliflozin; Linagliptin; Metformin Hydrochloride
ANDA #217049 |
Empagliflozin;Linagliptin;Metformin Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
Hydroxyurea
ANDA #218021 |
Hydroxyurea | Capsule; Oral | ORIG-1 | Qilu | Approved | |
Ivermectin
ANDA #210019 |
Ivermectin | Cream; Topical | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
Ivermectin
ANDA #210019 |
Ivermectin | Cream; Topical | SUPPL-3 | Teva Pharms Usa | Labeling | Approved |
Ivermectin
ANDA #210225 |
Ivermectin | Cream; Topical | SUPPL-4 | Padagis Israel | Labeling | Approved |
Jemperli
BLA #761174 |
Dostarlimab-Gxly | Injectable; Injection | SUPPL-10 | Glaxosmithkline | Labeling | Approved |
Letrozole
ANDA #203796 |
Letrozole | Tablet; Oral | SUPPL-1 | Hikma Pharms | Labeling | Approved |
Libtayo
BLA #761097 |
Cemiplimab-Rwlc | Injectable; Intravenous | SUPPL-25 | Regeneron Pharmaceuticals | Labeling | Approved |
Metoclopramide Hydrochloride
ANDA #073135 |
Metoclopramide Hydrochloride | Injectable; Injection | SUPPL-25 | Teva Pharms Usa | Labeling | Approved |
Metoclopramide Hydrochloride
ANDA #073135 |
Metoclopramide Hydrochloride | Injectable; Injection | SUPPL-28 | Teva Pharms Usa | Labeling | Approved |
Metoclopramide Hydrochloride
ANDA #073135 |
Metoclopramide Hydrochloride | Injectable; Injection | SUPPL-25 | Teva Pharms Usa | Labeling | Approved |
Metoclopramide Hydrochloride
ANDA #073135 |
Metoclopramide Hydrochloride | Injectable; Injection | SUPPL-28 | Teva Pharms Usa | Labeling | Approved |
Metoclopramide Hydrochloride
ANDA #073135 |
Metoclopramide Hydrochloride | Injectable; Injection | SUPPL-25 | Teva Pharms Usa | Labeling | Approved |
Metoclopramide Hydrochloride
ANDA #073135 |
Metoclopramide Hydrochloride | Injectable; Injection | SUPPL-28 | Teva Pharms Usa | Labeling | Approved |
Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-125 | Bristol Myers Squibb | Efficacy | Approved |
Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-128 | Bristol Myers Squibb | Labeling | Approved |
Opdualag
BLA #761234 |
Nivolumab;Relatlimab-Rmbw | Solution; Intravenous | SUPPL-6 | Bristol Myers Squibb | Labeling | Approved |
Pemetrexed Disodium
ANDA #207352 |
Pemetrexed Disodium | Powder; Intravenous | SUPPL-1 | Nang Kuang Pharm Co | Labeling | Approved |
Pemetrexed Disodium
ANDA #207352 |
Pemetrexed Disodium | Powder; Intravenous | SUPPL-1 | Nang Kuang Pharm Co | Labeling | Approved |
Pemetrexed Disodium
ANDA #207352 |
Pemetrexed Disodium | Powder; Intravenous | SUPPL-5 | Nang Kuang Pharm Co | Labeling | Approved |
Vancomycin Hydrochloride
ANDA #065490 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-14 | Strides Pharma | Labeling | Approved |
Vancomycin Hydrochloride
ANDA #065490 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-15 | Strides Pharma | Labeling | Approved |
Vancomycin Hydrochloride
ANDA #065490 |
Vancomycin Hydrochloride | Capsule; Oral | SUPPL-16 | Strides Pharma | Labeling | Approved |
Varenicline Tartrate
ANDA #217283 |
Varenicline Tartrate | Tablet; Oral | ORIG-1 | Avalanche Pharm | Approved |
March 5, 2024
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-14 | Aurolife Pharma Llc | Labeling | Approved |
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-15 | Aurolife Pharma Llc | Labeling | Approved |
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-16 | Aurolife Pharma Llc | Labeling | Approved |
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-14 | Aurolife Pharma Llc | Labeling | Approved |
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-15 | Aurolife Pharma Llc | Labeling | Approved |
Acetaminophen and Codeine Phosphate
ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | SUPPL-16 | Aurolife Pharma Llc | Labeling | Approved |
Amphetamine Sulfate
ANDA #213898 |
Amphetamine Sulfate | Tablet; Oral | SUPPL-2 | Dr Reddys Labs Sa | Labeling | Approved |
Aponvie
NDA #216457 |
Aprepitant | Emulsion; Intravenous | SUPPL-3 | Heron Theraps Inc | Labeling | Approved |
Aponvie
NDA #216457 |
Aprepitant | Emulsion; Intravenous | SUPPL-3 | Heron Theraps Inc | Labeling | Approved |
Capecitabine
ANDA #210203 |
Capecitabine | Tablet; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
Cinvanti
NDA #209296 |
Aprepitant | Emulsion; Intravenous | SUPPL-15 | Heron Theraps Inc | Labeling | Approved |
Cinvanti
NDA #209296 |
Aprepitant | Emulsion; Intravenous | SUPPL-15 | Heron Theraps Inc | Labeling | Approved |
Deferasirox
ANDA #211383 |
Deferasirox | Tablet; Oral | SUPPL-6 | Zydus Pharms | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-14 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-17 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-24 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-27 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-13 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-14 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-15 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-17 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-24 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-27 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-28 | Aurobindo Pharma | Labeling | Approved |
Fluoxetine Hydrochloride
ANDA #078619 |
Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-28 | Aurobindo Pharma | Labeling | Approved |
Gilteritinib
ANDA #217683 |
Gilteritinib | Tablet; Oral | ORIG-1 | Sandoz Inc | Tentative Approval | |
Jubbonti
BLA #761362 |
Denosumab-Bbdz | Injectable; Subcutaneous | ORIG-1 | Sandoz Inc | Approved | |
Oxcarbazepine
ANDA #207717 |
Oxcarbazepine | Tablet; Oral | ORIG-1 | Rubicon | Approved | |
Pantoprazole Sodium
ANDA #205675 |
Pantoprazole Sodium | Injectable; Intravenous | SUPPL-23 | Eugia Pharma | Labeling | Approved |
Pramipexole Dihydrochloride
ANDA #202633 |
Pramipexole Dihydrochloride | Tablet; Oral | SUPPL-14 | Aurobindo Pharma Ltd | Labeling | Approved |
Prolia
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-213 | Amgen | Efficacy | Approved |
Prolia
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-217 | Amgen | REMS | Approved |
Risperidone
ANDA #077493 |
Risperidone | Tablet; Oral | SUPPL-10 | Prinston Inc | Labeling | Approved |
Risperidone
ANDA #077543 |
Risperidone | Tablet; Oral | SUPPL-5 | Chartwell Molecular | Labeling | Approved |
Risperidone
ANDA #077543 |
Risperidone | Tablet; Oral | SUPPL-6 | Chartwell Molecular | Labeling | Approved |
Sorafenib Tosylate
ANDA #207012 |
Sorafenib Tosylate | Tablet; Oral | SUPPL-3 | Mylan | Labeling | Approved |
Sorafenib Tosylate
ANDA #207012 |
Sorafenib Tosylate | Tablet; Oral | SUPPL-3 | Mylan | Labeling | Approved |
Sorafenib Tosylate
ANDA #207012 |
Sorafenib Tosylate | Tablet; Oral | SUPPL-3 | Mylan | Labeling | Approved |
Tyenne
BLA #761275 |
Tocilizumab-Aazg | Injectable; Intravenous | ORIG-1 | Fresenius Kabi Usa | Approved | |
Tyenne
BLA #761275 |
Tocilizumab-Aazg | Injectable; Subcutaneous | ORIG-1 | Fresenius Kabi Usa | Approved | |
Wyost
BLA #761362 |
Denosumab-Bbdz | Injectable; Subcutaneous | ORIG-1 | Sandoz Inc | Approved | |
Xgeva
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-213 | Amgen | Efficacy | Approved |
Xgeva
BLA #125320 |
Denosumab | Injectable; Subcutaneous | SUPPL-217 | Amgen | REMS | Approved |