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 4, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bal
NDA #005939 |
Dimercaprol | Injectable; Injection | SUPPL-17 | Provepharm Sas | Labeling | Approved |
| Calcitonin-Salmon
ANDA #215864 |
Calcitonin Salmon | Injectable; Injection | ORIG-1 | Zydus Pharms | Approved | |
| Rocuronium Bromide
ANDA #220124 |
Rocuronium Bromide | Injectable; Injection | ORIG-1 | Aspiro | Approved |
March 3, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-14 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-14 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-18 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-20 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-22 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-22 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-11 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-11 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-14 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-18 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-20 | Istituto Bio Ita Spa | Labeling | Approved |
| Bosentan
ANDA #205699 |
Bosentan | Tablet; Oral | SUPPL-8 | Ph Health | REMS | Approved |
| Bosentan
ANDA #206987 |
Bosentan | Tablet; Oral | SUPPL-11 | Natco Pharma Ltd | REMS | Approved |
| Bosentan
ANDA #207110 |
Bosentan | Tablet; Oral | SUPPL-13 | Watson Labs Inc | REMS | Approved |
| Bosentan
ANDA #207760 |
Bosentan | Tablet; Oral | SUPPL-16 | Zydus Pharms | REMS | Approved |
| Bosentan
ANDA #209324 |
Bosentan | Tablet; Oral | SUPPL-20 | Sun Pharm | REMS | Approved |
| Bosentan
ANDA #209742 |
Bosentan | Tablet; Oral | SUPPL-16 | Amneal Pharms Co | REMS | Approved |
| Bosentan
ANDA #213154 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-7 | Natco Pharma Ltd | REMS | Approved |
| Bosentan
ANDA #213981 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-1 | Zydus Pharms | REMS | Approved |
| Fluticasone Propionate
ANDA #219602 |
Fluticasone Propionate | Aerosol, Metered; Inhalation | ORIG-1 | Glenmark Speclt | Approved | |
| Letrozole
ANDA #078190 |
Letrozole | Tablet; Oral | SUPPL-5 | Pharmobedient | Labeling | Approved |
| Letrozole
ANDA #078190 |
Letrozole | Tablet; Oral | SUPPL-10 | Pharmobedient | Labeling | Approved |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-50 | Actelion | REMS | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-17 | Actelion | REMS | Approved |
March 2, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bosulif
NDA #203341 |
Bosutinib Monohydrate | Tablet; Oral | SUPPL-27 | Pf Prism Cv | Labeling | Approved |
| Bosulif
NDA #217729 |
Bosutinib Monohydrate | Capsule; Oral | SUPPL-2 | Pf Prism Cv | Labeling | Approved |
| Imodium Multi-Symptom Relief
NDA #021140 |
Loperamide Hydrochloride; Simethicone | Tablet; Oral | SUPPL-39 | Kenvue Brands | Manufacturing (CMC) | Approved |
| Metronidazole
ANDA #070772 |
Metronidazole | Tablet; Oral | SUPPL-50 | Innogenix | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #209143 |
Moxifloxacin Hydrochloride | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Ondansetron Hydrochloride
ANDA #078539 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-16 | Aurobindo Pharma | Labeling | Approved |
| Oxcarbazepine
ANDA #219556 |
Oxcarbazepine | Tablet; Oral | ORIG-1 | Epic Pharma Llc | Approved | |
| Rivaroxaban
ANDA #218427 |
Rivaroxaban | For Suspension; Oral | ORIG-1 | Apotex | Approved | |
| Sodium Acetate
ANDA #218469 |
Sodium Acetate | Solution; Intravenous | SUPPL-2 | Amneal | Manufacturing (CMC) | Approved |
| Sodium Acetate
ANDA #218469 |
Sodium Acetate | Solution; Intravenous | SUPPL-2 | Amneal | Manufacturing (CMC) | Approved |
February 27, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Calcitriol
ANDA #219796 |
Calcitriol | Capsule; Oral | ORIG-1 | Humanwell Puracap | Approved | |
| Desmopressin Acetate
ANDA #219981 |
Desmopressin Acetate | Injectable; Injection | ORIG-1 | Caplin | Approved | |
| Diltiazem Hydrochloride
ANDA #218744 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Duloxetine
NDA #219131 |
Duloxetine | Capsule, Delayed Release | ORIG-1 | Almatica Pharma Llc | Type 5 - New Formulation or New Manufacturer | Approved |
| Izervay
NDA #217225 |
Avacincaptad Pegol Sodium | Solution; Intravitreal | SUPPL-4 | Astellas | Labeling | Approved |
| Palynziq
BLA #761079 |
Pegvaliase-Pqpz | Injectable; Injection | SUPPL-31 | Biomarin Pharm | Efficacy | Approved |
| Prezcobix
NDA #205395 |
Cobicistat; Darunavir Ethanolate | Tablet; Oral | SUPPL-29 | Janssen Prods | Efficacy | Approved |
| Prezcobix
NDA #220092 |
Darunavir and Cobicistat | Tablet, For Suspension; Oral | ORIG-1 | Janssen Prods | Type 3 - New Dosage Form | Approved |
| Reblozyl
BLA #761136 |
Luspatercept-Aamt | Powder; Subcutaneous | SUPPL-15 | Celgene Corp | Labeling | Approved |
| Siliq
BLA #761032 |
Brodalumab | Injectable; Injection | SUPPL-20 | Valeant Luxembourg | REMS | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-19 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-19 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-15 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-15 | Cubist Pharms Llc | Labeling | Approved |
| Sogroya
BLA #761156 |
Somapacitan-Beco | Solution; Subcutaneous | SUPPL-12 | Novo Nordisk Inc | Efficacy | Approved |
| Sogroya
BLA #761156 |
Somapacitan-Beco | Solution; Subcutaneous | SUPPL-14 | Novo Nordisk Inc | Efficacy | Approved |
| Sogroya
BLA #761156 |
Somapacitan-Beco | Solution; Subcutaneous | SUPPL-15 | Novo Nordisk Inc | Efficacy | Approved |
| Yuviwel
NDA #219164 |
Navepegritide | Powder; Subcutaneous | ORIG-1 | Ascendis | Type 1 - New Molecular Entity | Approved |
| Zepzelca
NDA #213702 |
Lurbinectedin | Powder; Intravenous | SUPPL-12 | Jazz | Labeling | Approved |
March 4, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bal
NDA #005939 |
Dimercaprol | Injectable; Injection | SUPPL-17 | Provepharm Sas | Labeling | Approved |
| Calcitonin-Salmon
ANDA #215864 |
Calcitonin Salmon | Injectable; Injection | ORIG-1 | Zydus Pharms | Approved | |
| Rocuronium Bromide
ANDA #220124 |
Rocuronium Bromide | Injectable; Injection | ORIG-1 | Aspiro | Approved |
March 3, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-14 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-14 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-18 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-20 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-22 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065222 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-22 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-11 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-11 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-14 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-18 | Istituto Bio Ita Spa | Labeling | Approved |
| Ampicillin and Sulbactam
ANDA #065314 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-20 | Istituto Bio Ita Spa | Labeling | Approved |
| Bosentan
ANDA #205699 |
Bosentan | Tablet; Oral | SUPPL-8 | Ph Health | REMS | Approved |
| Bosentan
ANDA #206987 |
Bosentan | Tablet; Oral | SUPPL-11 | Natco Pharma Ltd | REMS | Approved |
| Bosentan
ANDA #207110 |
Bosentan | Tablet; Oral | SUPPL-13 | Watson Labs Inc | REMS | Approved |
| Bosentan
ANDA #207760 |
Bosentan | Tablet; Oral | SUPPL-16 | Zydus Pharms | REMS | Approved |
| Bosentan
ANDA #209324 |
Bosentan | Tablet; Oral | SUPPL-20 | Sun Pharm | REMS | Approved |
| Bosentan
ANDA #209742 |
Bosentan | Tablet; Oral | SUPPL-16 | Amneal Pharms Co | REMS | Approved |
| Bosentan
ANDA #213154 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-7 | Natco Pharma Ltd | REMS | Approved |
| Bosentan
ANDA #213981 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-1 | Zydus Pharms | REMS | Approved |
| Fluticasone Propionate
ANDA #219602 |
Fluticasone Propionate | Aerosol, Metered; Inhalation | ORIG-1 | Glenmark Speclt | Approved | |
| Letrozole
ANDA #078190 |
Letrozole | Tablet; Oral | SUPPL-5 | Pharmobedient | Labeling | Approved |
| Letrozole
ANDA #078190 |
Letrozole | Tablet; Oral | SUPPL-10 | Pharmobedient | Labeling | Approved |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-50 | Actelion | REMS | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-17 | Actelion | REMS | Approved |
March 2, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bosulif
NDA #203341 |
Bosutinib Monohydrate | Tablet; Oral | SUPPL-27 | Pf Prism Cv | Labeling | Approved |
| Bosulif
NDA #217729 |
Bosutinib Monohydrate | Capsule; Oral | SUPPL-2 | Pf Prism Cv | Labeling | Approved |
| Imodium Multi-Symptom Relief
NDA #021140 |
Loperamide Hydrochloride; Simethicone | Tablet; Oral | SUPPL-39 | Kenvue Brands | Manufacturing (CMC) | Approved |
| Metronidazole
ANDA #070772 |
Metronidazole | Tablet; Oral | SUPPL-50 | Innogenix | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #209143 |
Moxifloxacin Hydrochloride | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Ondansetron Hydrochloride
ANDA #078539 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-16 | Aurobindo Pharma | Labeling | Approved |
| Oxcarbazepine
ANDA #219556 |
Oxcarbazepine | Tablet; Oral | ORIG-1 | Epic Pharma Llc | Approved | |
| Rivaroxaban
ANDA #218427 |
Rivaroxaban | For Suspension; Oral | ORIG-1 | Apotex | Approved | |
| Sodium Acetate
ANDA #218469 |
Sodium Acetate | Solution; Intravenous | SUPPL-2 | Amneal | Manufacturing (CMC) | Approved |
| Sodium Acetate
ANDA #218469 |
Sodium Acetate | Solution; Intravenous | SUPPL-2 | Amneal | Manufacturing (CMC) | Approved |
February 27, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Calcitriol
ANDA #219796 |
Calcitriol | Capsule; Oral | ORIG-1 | Humanwell Puracap | Approved | |
| Desmopressin Acetate
ANDA #219981 |
Desmopressin Acetate | Injectable; Injection | ORIG-1 | Caplin | Approved | |
| Diltiazem Hydrochloride
ANDA #218744 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Duloxetine
NDA #219131 |
Duloxetine | Capsule, Delayed Release | ORIG-1 | Almatica Pharma Llc | Type 5 - New Formulation or New Manufacturer | Approved |
| Izervay
NDA #217225 |
Avacincaptad Pegol Sodium | Solution; Intravitreal | SUPPL-4 | Astellas | Labeling | Approved |
| Palynziq
BLA #761079 |
Pegvaliase-Pqpz | Injectable; Injection | SUPPL-31 | Biomarin Pharm | Efficacy | Approved |
| Prezcobix
NDA #205395 |
Cobicistat; Darunavir Ethanolate | Tablet; Oral | SUPPL-29 | Janssen Prods | Efficacy | Approved |
| Prezcobix
NDA #220092 |
Darunavir and Cobicistat | Tablet, For Suspension; Oral | ORIG-1 | Janssen Prods | Type 3 - New Dosage Form | Approved |
| Reblozyl
BLA #761136 |
Luspatercept-Aamt | Powder; Subcutaneous | SUPPL-15 | Celgene Corp | Labeling | Approved |
| Siliq
BLA #761032 |
Brodalumab | Injectable; Injection | SUPPL-20 | Valeant Luxembourg | REMS | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-19 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-19 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-15 | Cubist Pharms Llc | Labeling | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-15 | Cubist Pharms Llc | Labeling | Approved |
| Sogroya
BLA #761156 |
Somapacitan-Beco | Solution; Subcutaneous | SUPPL-12 | Novo Nordisk Inc | Efficacy | Approved |
| Sogroya
BLA #761156 |
Somapacitan-Beco | Solution; Subcutaneous | SUPPL-14 | Novo Nordisk Inc | Efficacy | Approved |
| Sogroya
BLA #761156 |
Somapacitan-Beco | Solution; Subcutaneous | SUPPL-15 | Novo Nordisk Inc | Efficacy | Approved |
| Yuviwel
NDA #219164 |
Navepegritide | Powder; Subcutaneous | ORIG-1 | Ascendis | Type 1 - New Molecular Entity | Approved |
| Zepzelca
NDA #213702 |
Lurbinectedin | Powder; Intravenous | SUPPL-12 | Jazz | Labeling | Approved |
February 26, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Brivaracetam
ANDA #219583 |
Brivaracetam | Tablet | ORIG-1 | Shandong New Time Pharmaceutical Co Ltd | Tentative Approval | |
| Bumetanide
ANDA #220427 |
Bumetanide | Injectable; Injection | ORIG-1 | Anthea Pharma | Approved | |
| Dalbavancin Hydrochloride
ANDA #218602 |
Dalbavancin Hydrochloride | Powder; Intravenous | ORIG-1 | Long Grove Pharms | Approved | |
| Dapsone
ANDA #220103 |
Dapsone | Tablet; Oral | ORIG-1 | Zydus Lifesciences | Approved | |
| Ensacove
NDA #218171 |
Ensartinib Hydrochloride | Capsule; Oral | SUPPL-3 | Xcovery | Labeling | Approved |
| Hernexeos
NDA #219042 |
Zongertinib | Tablet; Oral | SUPPL-1 | Boehringer Ingelheim | Efficacy | Approved |
| Hernexeos
NDA #219042 |
Zongertinib | Tablet; Oral | SUPPL-1 | Boehringer Ingelheim | Efficacy | Approved |
| Ivermectin
ANDA #216863 |
Ivermectin | Tablet; Oral | ORIG-1 | Zydus Lifesciences | Approved | |
| Jascayd
NDA #218764 |
Nerandomilast | Tablet; Oral | SUPPL-1 | Boehringer Ingelheim | Labeling | Approved |
| Ondansetron Hydrochloride
ANDA #077729 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-4 | Taro | Labeling | Approved |
| Ondansetron Hydrochloride
ANDA #077729 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-5 | Taro | Labeling | Approved |
| Phytonadione
ANDA #216852 |
Phytonadione | Injectable; Injection | ORIG-1 | Baxter Hlthcare Corp | Approved | |
| Phytonadione
ANDA #220454 |
Phytonadione | Tablet; Oral | ORIG-1 | Sinotherapeutics Inc | Approved | |
| Rizafilm
NDA #205394 |
Rizatriptan Benzoate | Film; Oral | SUPPL-5 | Gensco | Efficacy | Approved |
| Vyvgart Hytrulo
BLA #761304 |
Efgartigimod Alfa and Hyaluronidase-Qvfc | Injectable; Injection | SUPPL-19 | Argenx Bv | Labeling | Approved |
| Xeomin
BLA #125360 |
Incobotulinumtoxina | Injectable; Injection | SUPPL-110 | Merz Pharms | Labeling | Approved |
February 25, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alectinib
ANDA #217441 |
Alectinib | Capsule | ORIG-1 | Natco Pharma Ltd | Tentative Approval | |
| Anastrozole
ANDA #206037 |
Anastrozole | Tablet; Oral | SUPPL-7 | Beijing Yiling | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #075584 |
Bupropion Hydrochloride | Tablet; Oral | SUPPL-61 | Senores Pharms | Labeling | Approved |
| Cetirizine Hydrochloride
ANDA #220335 |
Cetirizine Hydrochloride | Solution; Oral | ORIG-1 | Rubicon Research | Approved | |
| Desmoda
NDA #219873 |
Desmopressin Acetate | Solution; Oral | ORIG-1 | Eton | Type 3 - New Dosage Form | Approved |
| Dexmedetomidine Hydrochloride
ANDA #220315 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Dr Reddys | Approved | |
| Empagliflozin and Metformin Hydrochloride
ANDA #220511 |
Empagliflozin, Metformin Hydrochloride | Tablet, Extended Release | ORIG-1 | Ajanta Pharma Ltd | Tentative Approval | |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-66 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-66 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #761133 |
Vedolizumab | Injectable; Injection | SUPPL-14 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #761133 |
Vedolizumab | Injectable; Injection | SUPPL-14 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #761133 |
Vedolizumab | Injectable; Intravenous | SUPPL-14 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #761133 |
Vedolizumab | Injectable; Intravenous | SUPPL-14 | Takeda Pharms Usa | Labeling | Approved |
| Everolimus
ANDA #219533 |
Everolimus | Tablet; Oral | ORIG-1 | Eugia Pharma | Approved | |
| Hydrocortisone
ANDA #220329 |
Hydrocortisone | Tablet; Oral | ORIG-1 | Appco | Approved | |
| Juxtapid
NDA #203858 |
Lomitapide Mesylate | Capsule; Oral | SUPPL-27 | Chiesi | REMS | Approved |
| Lamotrigine
ANDA #217278 |
Lamotrigine | Tablet, Orally Disintegrating; Oral | ORIG-1 | Alembic | Approved | |
| Macitentan
ANDA #211000 |
Macitentan | Tablet | ORIG-1 | Amneal Ireland Ltd | Tentative Approval | |
| Neffy
NDA #214697 |
Epinephrine | Spray; Nasal | SUPPL-2 | Ars Pharms Operation | Efficacy | Tentative Approval |
| Ondansetron Hydrochloride
ANDA #076183 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-19 | Dr Reddys Labs Ltd | Labeling | Approved |
| Ondansetron Hydrochloride
ANDA #076930 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-12 | Rising | Labeling | Approved |
| Ondansetron Hydrochloride
ANDA #076930 |
Ondansetron Hydrochloride | Tablet; Oral | SUPPL-12 | Rising | Labeling | Approved |
| Palbociclib
ANDA #212980 |
Palbociclib | Capsule | ORIG-1 | Cipla Limited | Tentative Approval | |
| Saxenda
NDA #206321 |
Liraglutide | Solution; Subcutaneous | SUPPL-25 | Novo | Labeling | Approved |
| Saxenda
NDA #206321 |
Liraglutide | Solution; Subcutaneous | SUPPL-25 | Novo | Labeling | Approved |
| Wegovy
NDA #215256 |
Semaglutide | Solution; Subcutaneous | SUPPL-33 | Novo | Labeling | Approved |
| Wegovy
NDA #215256 |
Semaglutide | Solution; Subcutaneous | SUPPL-33 | Novo | Labeling | Approved |
| Wegovy
NDA #218316 |
Semaglutide | Tablet; Oral | SUPPL-4 | Novo | Labeling | Approved |
| Wegovy
NDA #218316 |
Semaglutide | Tablet; Oral | SUPPL-4 | Novo | Labeling | Approved |
| Zepbound
NDA #217806 |
Tirzepatide | Solution; Subcutaneous | SUPPL-42 | Eli Lilly and Co | Labeling | Approved |
| Zepbound (Autoinjector)
NDA #217806 |
Tirzepatide | Solution; Subcutaneous | SUPPL-42 | Eli Lilly and Co | Labeling | Approved |
| Zepbound Kwikpen
NDA #217806 |
Tirzepatide | Solution; Subcutaneous | SUPPL-42 | Eli Lilly and Co | Labeling | Approved |
| Zioptan
NDA #202514 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-8 | Thea Pharma | Labeling | Approved |
February 24, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Braftovi
NDA #210496 |
Encorafenib | Capsule; Oral | SUPPL-19 | Array Biopharma Inc | Efficacy | Approved |
| Braftovi
NDA #210496 |
Encorafenib | Capsule; Oral | SUPPL-21 | Array Biopharma Inc | Efficacy | Approved |
| Clomiphene Citrate
ANDA #075528 |
Clomiphene Citrate | Tablet; Oral | SUPPL-28 | Cosette | Labeling | Approved |
| Clomiphene Citrate
ANDA #075528 |
Clomiphene Citrate | Tablet; Oral | SUPPL-28 | Cosette | Labeling | Approved |
| Fingolimod Hydrochloride
ANDA #207983 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-2 | Aurobindo Pharma Ltd | Labeling | Approved |
| Fingolimod Hydrochloride
ANDA #207983 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-2 | Aurobindo Pharma Ltd | Labeling | Approved |
| Follistim Aq
BLA #021211 |
Follitropin Alfa/Beta | Injectable; Subcutaneous | SUPPL-47 | Organon Usa Llc | Labeling | Approved |
| Follistim Aq
BLA #021211 |
Follitropin Alfa/Beta | Injectable; Subcutaneous | SUPPL-47 | Organon Usa Llc | Labeling | Approved |
| Gabapentin
ANDA #209855 |
Gabapentin | Tablet; Oral | SUPPL-2 | Ipca Labs Ltd | Labeling | Approved |
| Gabapentin
ANDA #209855 |
Gabapentin | Tablet; Oral | SUPPL-2 | Ipca Labs Ltd | Labeling | Approved |
| Liraglutide
ANDA #217063 |
Liraglutide | Solution; Subcutaneous | ORIG-1 | Biocon Pharma | Approved | |
| Liraglutide
ANDA #217234 |
Liraglutide | Solution; Subcutaneous | ORIG-1 | Orbicular | Approved | |
| Lurasidone Hydrochloride
ANDA #212091 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #212091 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #212091 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-5 | Chartwell Rx | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #212091 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-1 | Chartwell Rx | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #212091 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-5 | Chartwell Rx | Labeling | Approved |
| Micafungin Sodium
ANDA #219518 |
Micafungin Sodium | Injectable; Intravenous | ORIG-1 | Yichang Humanwell | Approved | |
| Mupirocin
ANDA #065192 |
Mupirocin | Ointment; Topical | SUPPL-9 | Fougera Pharms | Labeling | Approved |
| Mupirocin
ANDA #065192 |
Mupirocin | Ointment; Topical | SUPPL-10 | Fougera Pharms | Labeling | Approved |
| Mupirocin
ANDA #065192 |
Mupirocin | Ointment; Topical | SUPPL-13 | Fougera Pharms | Labeling | Approved |
| Pregabalin
ANDA #218529 |
Pregabalin | Capsule; Oral | ORIG-1 | Fourrts Labs | Approved | |
| Robinul
NDA #017558 |
Glycopyrrolate | Injectable; Injection | SUPPL-66 | Hikma | Labeling | Approved |
| Sitagliptin and Metformin Hydrochloride
ANDA #214859 |
Sitagliptin and Metformin Hydrochloride | Tablet | ORIG-1 | Aurobindo Pharma Limited | Tentative Approval | |
| Sitagliptin Phosphate
ANDA #214784 |
Sitagliptin Phosphate | Tablet; Oral | ORIG-1 | Ajanta Pharma Ltd | Tentative Approval | |
| Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride
ANDA #220327 |
Sodium Sulfate, Magnesium Sulfate, Potassium Chloride | Tablet | ORIG-1 | Appco Pharma Llc | Tentative Approval |
February 23, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Brivaracetam
ANDA #214875 |
Brivaracetam | Tablet; Oral | ORIG-1 | Apotex | Approved | |
| Brivaracetam
ANDA #214880 |
Brivaracetam | Solution; Intravenous | ORIG-1 | Micro Labs | Approved | |
| Brivaracetam
ANDA #214924 |
Brivaracetam | Solution; Intravenous | ORIG-1 | Msn | Approved | |
| Brivaracetam
ANDA #218249 |
Brivaracetam | Solution; Intravenous | ORIG-1 | Hainan Poly | Approved | |
| Brivaracetam
ANDA #218494 |
Brivaracetam | Solution; Oral | ORIG-1 | Zhejiang Poly Pharm | Approved | |
| Brivaracetam
ANDA #219772 |
Brivaracetam | Solution; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Brivaracetam
ANDA #220164 |
Brivaracetam | Solution; Oral | ORIG-1 | Lupin | Approved | |
| Brivaracetam
ANDA #220385 |
Brivaracetam | Solution; Oral | ORIG-1 | Indoco | Approved | |
| Brivaracetam
ANDA #220470 |
Brivaracetam | Tablet; Oral | ORIG-1 | Centaur Pharms Pvt | Approved | |
| Diltiazem Hydrochloride
ANDA #206534 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Diltiazem Hydrochloride
ANDA #206534 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Zydus Pharms | Labeling | Approved |
| Diltiazem Hydrochloride
ANDA #206534 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-7 | Zydus Pharms | Labeling | Approved |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-75 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Efinaconazole
ANDA #212027 |
Efinaconazole | Solution; Topical | ORIG-1 | Alembic | Approved | |
| Ipratropium Bromide
ANDA #217953 |
Ipratropium Bromide | Aerosol, Metered; Inhalation | ORIG-1 | Armstrong Pharms | Approved | |
| Loargys
BLA #761211 |
Pegzilarginase-Nbln | Injectable; Injection | ORIG-1 | Immedica Pharma Ab | Type 1 - New Molecular Entity | Approved |
| Mycophenolate Mofetil
ANDA #214871 |
Mycophenolate Mofetil | For Suspension; Oral | SUPPL-11 | Amneal | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #214871 |
Mycophenolate Mofetil | For Suspension; Oral | SUPPL-11 | Amneal | Labeling | Approved |
| Pregabalin
ANDA #091040 |
Pregabalin | Capsule; Oral | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Pregabalin
ANDA #091040 |
Pregabalin | Capsule; Oral | SUPPL-3 | Lupin Ltd | Labeling | Approved |
| Pregabalin
ANDA #091040 |
Pregabalin | Capsule; Oral | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Pregabalin
ANDA #207623 |
Pregabalin | Solution; Oral | SUPPL-3 | Alkem Labs Ltd | Labeling | Approved |
| Pregabalin
ANDA #207623 |
Pregabalin | Solution; Oral | SUPPL-3 | Alkem Labs Ltd | Labeling | Approved |
| Sitagliptin Phosphate
ANDA #215155 |
Sitagliptin Phosphate | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Tentative Approval | |
| Sodium Phosphates
ANDA #220683 |
Sodium Phosphate, Dibasic, Heptahydrate; Sodium Phosphate, Monobasic, Monohydrate | Solution; Intravenous | ORIG-1 | Caplin | Approved | |
| Sustol
NDA #022445 |
Granisetron | Injectable; Subcutaneous | SUPPL-14 | Heron Theraps Inc | Labeling | Approved |
| Sustol
NDA #022445 |
Granisetron | Injectable; Subcutaneous | SUPPL-14 | Heron Theraps Inc | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-8 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-9 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-10 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-12 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-13 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-7 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-8 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-9 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-10 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-11 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-12 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-13 | Sun Pharm Inds Ltd | Labeling | Approved |
| Topiramate
ANDA #076327 |
Topiramate | Tablet; Oral | SUPPL-14 | Sun Pharm Inds Ltd | Labeling | Approved |