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.
April 23, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Fylnetra
BLA #761084 |
Pegfilgrastim-Pbbk | Injectable; Injection | SUPPL-7 | Kashiv Biosciences Llc | Approved | |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-20 | Pfizer | Efficacy | Approved |
| Ibrance
NDA #212436 |
Palbociclib | Tablet; Oral | SUPPL-8 | Pfizer | Efficacy | Approved |
| Penpulimab-Kcqx
BLA #761258 |
Penpulimab-Kcqx | Injectable; Intravenous | ORIG-1 | Akeso Biopharma | Type 1 - New Molecular Entity | Approved |
April 22, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Beizray
NDA #218711 |
Docetaxel | Solution; Intravenous | SUPPL-1 | Zhuhai | Labeling | Approved |
| Dasatinib
ANDA #216547 |
Dasatinib | Tablet; Oral | ORIG-1 | Eugia Pharma | Approved | |
| Fosamprenavir Calcium
ANDA #204024 |
Fosamprenavir Calcium | Tablet; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Fosamprenavir Calcium
ANDA #204024 |
Fosamprenavir Calcium | Tablet; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Fosamprenavir Calcium
ANDA #204024 |
Fosamprenavir Calcium | Tablet; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Hydroxyzine Hydrochloride
ANDA #217652 |
Hydroxyzine Hydrochloride | Tablet; Oral | SUPPL-3 | Graviti Pharms | Labeling | Approved |
| Letrozole
ANDA #090289 |
Letrozole | Tablet; Oral | SUPPL-11 | Teva Pharms | Labeling | Approved |
| Premarin
NDA #004782 |
Estrogens, Conjugated | Tablet; Oral | SUPPL-179 | Wyeth Pharms | Labeling | Approved |
| Premarin
NDA #020216 |
Estrogens, Conjugated | Cream; Topical, Vaginal | SUPPL-84 | Wyeth Pharms | Labeling | Approved |
| Premphase 14/14
NDA #020527 |
Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet; Oral-28 | SUPPL-67 | Wyeth Pharms | Labeling | Approved |
| Prempro
NDA #020527 |
Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet; Oral-28 | SUPPL-67 | Wyeth Pharms | Labeling | Approved |
| Qamzova
NDA #217593 |
Meloxicam | Injectable; Injection | ORIG-1 | Nanjing Delova Biotech Co Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Siponimod
ANDA #218444 |
Siponimod | Tablet; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-11 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-2 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-3 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-5 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-6 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-12 | Beigene | Efficacy | Approved |
| Vardenafil Hydrochloride
ANDA #204632 |
Vardenafil Hydrochloride | Tablet; Oral | SUPPL-6 | Macleods Pharms Ltd | Labeling | Approved |
| Vardenafil Hydrochloride
ANDA #204632 |
Vardenafil Hydrochloride | Tablet; Oral | SUPPL-6 | Macleods Pharms Ltd | Labeling | Approved |
April 21, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Dostinex
NDA #020664 |
Cabergoline | Tablet; Oral | SUPPL-16 | Pfizer | Labeling | Approved |
| Hydralazine Hydrochloride
ANDA #086242 |
Hydralazine Hydrochloride | Tablet; Oral | SUPPL-44 | Heritage | Labeling | Approved |
| Hydralazine Hydrochloride
ANDA #086242 |
Hydralazine Hydrochloride | Tablet; Oral | SUPPL-44 | Heritage | Labeling | Approved |
| Hydralazine Hydrochloride
ANDA #086242 |
Hydralazine Hydrochloride | Tablet; Oral | SUPPL-51 | Heritage | Labeling | Approved |
| Imatinib Mesylate
ANDA #212193 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Cspc Ouyi | Approved | |
| Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-174 | Merck Sharp Dohme | Efficacy | Approved |
| Lithium Carbonate
ANDA #205532 |
Lithium Carbonate | Tablet, Extended Release; Oral | SUPPL-9 | Heritage Pharma | Labeling | Approved |
| Lithium Carbonate
ANDA #205532 |
Lithium Carbonate | Tablet, Extended Release; Oral | SUPPL-9 | Heritage Pharma | Labeling | Approved |
| Lithium Carbonate
ANDA #205532 |
Lithium Carbonate | Tablet, Extended Release; Oral | SUPPL-14 | Heritage Pharma | Labeling | Approved |
| Mekinist
NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-39 | Novartis | Labeling | Approved |
| Nemluvio
BLA #761390 |
Nemolizumab-Ilto | Injectable; Injection | SUPPL-1 | Galderma Labs Lp | Labeling | Approved |
| Phexxi
NDA #208352 |
Citric Acid; Lactic Acid; Potassium Bitartrate | Gel; Vaginal | SUPPL-5 | Evofem Inc | Labeling | Approved |
| Phexxi
NDA #208352 |
Citric Acid; Lactic Acid; Potassium Bitartrate | Gel; Vaginal | SUPPL-5 | Evofem Inc | Labeling | Approved |
| Potassium Chloride
ANDA #205549 |
Potassium Chloride | Capsule, Extended Release; Oral | SUPPL-1 | Strides Pharma | Labeling | Approved |
| Zidovudine
ANDA #078128 |
Zidovudine | Capsule; Oral | SUPPL-18 | Aurobindo Pharma Ltd | Labeling | Approved |
| Zidovudine
ANDA #078128 |
Zidovudine | Capsule; Oral | SUPPL-22 | Aurobindo Pharma Ltd | Labeling | Approved |
April 18, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bkemv
BLA #761333 |
Eculizumab-Aeeb | Injectable; Injection | SUPPL-4 | Amgen Inc | REMS | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-37 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-37 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-40 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-37 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-40 | Sciegen Pharms Inc | Labeling | Approved |
| Colesevelam Hydrochloride
ANDA #204893 |
Colesevelam Hydrochloride | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Fesoterodine Fumarate
ANDA #204893 |
Fesoterodine Fumarate | Tablet, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Memantine Hydrochloride
ANDA #206032 |
Memantine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-6 | Rising | Manufacturing (CMC) | Approved |
| Memantine Hydrochloride
ANDA #206032 |
Memantine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-6 | Rising | Manufacturing (CMC) | Approved |
| Neupogen
BLA #103353 |
Filgrastim | Syringe | SUPPL-5201 | Amgen | Labeling | Approved |
| Neupogen
BLA #103353 |
Filgrastim | Vial | SUPPL-5201 | Amgen | Labeling | Approved |
| Ojjaara
NDA #216873 |
Momelotinib Dihydrochloride | Tablet; Oral | SUPPL-2 | Glaxosmithkline | Labeling | Approved |
| Prednisolone Sodium Phosphate
ANDA #076913 |
Prednisolone Sodium Phosphate | Solution; Oral | SUPPL-16 | Pharm Assoc | Manufacturing (CMC) | Approved |
| Prednisolone Sodium Phosphate
ANDA #076913 |
Prednisolone Sodium Phosphate | Solution; Oral | SUPPL-16 | Pharm Assoc | Manufacturing (CMC) | Approved |
| Simponi
BLA #125289 |
Golimumab | Injectable; Injection | SUPPL-155 | Centocor Ortho Biotech Inc | Labeling | Approved |
| Simponi Aria
BLA #125433 |
Golimumab | Injectable; Injection | SUPPL-36 | Janssen Biotech | Labeling | Approved |
| Voriconazole
NDA #208562 |
Voriconazole | Injectable; Injection | SUPPL-11 | Hikma | Labeling | Approved |
| Voriconazole
NDA #208562 |
Voriconazole | Injectable; Intravenous | SUPPL-11 | Hikma | Labeling | Approved |
| Wainua (Autoinjector)
NDA #217388 |
Eplontersen Sodium | Solution; Subcutaneous | SUPPL-4 | Astrazeneca Ab | Labeling | Approved |
| Wainua (Autoinjector)
NDA #217388 |
Eplontersen Sodium | Solution; Subcutaneous | SUPPL-4 | Astrazeneca Ab | Labeling | Approved |
April 17, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Axitinib
ANDA #211650 |
Axitinib | Tablet; Oral | ORIG-1 | Apotex Inc | Tentative Approval | |
| Camzyos
NDA #214998 |
Mavacamten | Capsule; Oral | SUPPL-10 | Bristol | Efficacy | Approved |
| Children's Claritin
NDA #021891 |
Loratadine | Tablet, Chewable; Oral | SUPPL-46 | Bayer Healthcare Llc | Manufacturing (CMC) | Approved |
| Claritin
NDA #019658 |
Loratadine | Tablet; Oral | SUPPL-62 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin
NDA #021891 |
Loratadine | Tablet, Chewable; Oral | SUPPL-46 | Bayer Healthcare Llc | Manufacturing (CMC) | Approved |
| Claritin Hives Relief
NDA #019658 |
Loratadine | Tablet; Oral | SUPPL-62 | Bayer Healthcare Llc | Labeling | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205128 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | SUPPL-2 | Actavis Labs Ut Inc | Labeling | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205128 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | SUPPL-2 | Actavis Labs Ut Inc | Labeling | Approved |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-51 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Eliquis
NDA #202155 |
Apixaban | Tablet; Oral | SUPPL-40 | Bristol Myers Squibb | Efficacy | Approved |
| Eliquis
NDA #202155 |
Apixaban | Tablet; Oral | SUPPL-39 | Bristol Myers Squibb | Efficacy | Approved |
| Eliquis
NDA #220073 |
Apixaban | Suspension; Oral | ORIG-1 | Bristol Myers Squibb | Type 3 - New Dosage Form | Approved |
| Eliquis
NDA #220073 |
Apixaban | Tablet; Oral | ORIG-1 | Bristol Myers Squibb | Type 3 - New Dosage Form | Approved |
| Esomeprazole Sodium
ANDA #205379 |
Esomeprazole Sodium | Injectable; Intravenous | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Esomeprazole Sodium
ANDA #205379 |
Esomeprazole Sodium | Injectable; Intravenous | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
ANDA #215232 |
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Linezolid
ANDA #206454 |
Linezolid | Solution; Intravenous | SUPPL-3 | Hikma | Labeling | Approved |
| Nicardipine Hydrochloride
ANDA #074928 |
Nicardipine Hydrochloride | Capsule; Oral | SUPPL-8 | Epic Pharma Llc | Labeling | Approved |
| Olmesartan Medoxomil
ANDA #205482 |
Olmesartan Medoxomil | Tablet; Oral | SUPPL-8 | Jubilant Generics | Labeling | Approved |
| Pantoprazole Sodium
ANDA #077674 |
Pantoprazole Sodium | Injectable; Intravenous | SUPPL-12 | Sun Pharm | Labeling | Approved |
| Pantoprazole Sodium
ANDA #077674 |
Pantoprazole Sodium | Injectable; Intravenous | SUPPL-15 | Sun Pharm | Labeling | Approved |
April 23, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Fylnetra
BLA #761084 |
Pegfilgrastim-Pbbk | Injectable; Injection | SUPPL-7 | Kashiv Biosciences Llc | Approved | |
| Ibrance
NDA #207103 |
Palbociclib | Capsule; Oral | SUPPL-20 | Pfizer | Efficacy | Approved |
| Ibrance
NDA #212436 |
Palbociclib | Tablet; Oral | SUPPL-8 | Pfizer | Efficacy | Approved |
| Penpulimab-Kcqx
BLA #761258 |
Penpulimab-Kcqx | Injectable; Intravenous | ORIG-1 | Akeso Biopharma | Type 1 - New Molecular Entity | Approved |
April 22, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Beizray
NDA #218711 |
Docetaxel | Solution; Intravenous | SUPPL-1 | Zhuhai | Labeling | Approved |
| Dasatinib
ANDA #216547 |
Dasatinib | Tablet; Oral | ORIG-1 | Eugia Pharma | Approved | |
| Fosamprenavir Calcium
ANDA #204024 |
Fosamprenavir Calcium | Tablet; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Fosamprenavir Calcium
ANDA #204024 |
Fosamprenavir Calcium | Tablet; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Fosamprenavir Calcium
ANDA #204024 |
Fosamprenavir Calcium | Tablet; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Hydroxyzine Hydrochloride
ANDA #217652 |
Hydroxyzine Hydrochloride | Tablet; Oral | SUPPL-3 | Graviti Pharms | Labeling | Approved |
| Letrozole
ANDA #090289 |
Letrozole | Tablet; Oral | SUPPL-11 | Teva Pharms | Labeling | Approved |
| Premarin
NDA #004782 |
Estrogens, Conjugated | Tablet; Oral | SUPPL-179 | Wyeth Pharms | Labeling | Approved |
| Premarin
NDA #020216 |
Estrogens, Conjugated | Cream; Topical, Vaginal | SUPPL-84 | Wyeth Pharms | Labeling | Approved |
| Premphase 14/14
NDA #020527 |
Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet; Oral-28 | SUPPL-67 | Wyeth Pharms | Labeling | Approved |
| Prempro
NDA #020527 |
Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet; Oral-28 | SUPPL-67 | Wyeth Pharms | Labeling | Approved |
| Qamzova
NDA #217593 |
Meloxicam | Injectable; Injection | ORIG-1 | Nanjing Delova Biotech Co Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Siponimod
ANDA #218444 |
Siponimod | Tablet; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-11 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-2 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-3 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-5 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-6 | Beigene | Efficacy | Approved |
| Tevimbra
BLA #761232 |
Tislelizumab-Jsgr | Injection; Solution | SUPPL-12 | Beigene | Efficacy | Approved |
| Vardenafil Hydrochloride
ANDA #204632 |
Vardenafil Hydrochloride | Tablet; Oral | SUPPL-6 | Macleods Pharms Ltd | Labeling | Approved |
| Vardenafil Hydrochloride
ANDA #204632 |
Vardenafil Hydrochloride | Tablet; Oral | SUPPL-6 | Macleods Pharms Ltd | Labeling | Approved |
April 21, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Dostinex
NDA #020664 |
Cabergoline | Tablet; Oral | SUPPL-16 | Pfizer | Labeling | Approved |
| Hydralazine Hydrochloride
ANDA #086242 |
Hydralazine Hydrochloride | Tablet; Oral | SUPPL-44 | Heritage | Labeling | Approved |
| Hydralazine Hydrochloride
ANDA #086242 |
Hydralazine Hydrochloride | Tablet; Oral | SUPPL-44 | Heritage | Labeling | Approved |
| Hydralazine Hydrochloride
ANDA #086242 |
Hydralazine Hydrochloride | Tablet; Oral | SUPPL-51 | Heritage | Labeling | Approved |
| Imatinib Mesylate
ANDA #212193 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Cspc Ouyi | Approved | |
| Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-174 | Merck Sharp Dohme | Efficacy | Approved |
| Lithium Carbonate
ANDA #205532 |
Lithium Carbonate | Tablet, Extended Release; Oral | SUPPL-9 | Heritage Pharma | Labeling | Approved |
| Lithium Carbonate
ANDA #205532 |
Lithium Carbonate | Tablet, Extended Release; Oral | SUPPL-9 | Heritage Pharma | Labeling | Approved |
| Lithium Carbonate
ANDA #205532 |
Lithium Carbonate | Tablet, Extended Release; Oral | SUPPL-14 | Heritage Pharma | Labeling | Approved |
| Mekinist
NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-39 | Novartis | Labeling | Approved |
| Nemluvio
BLA #761390 |
Nemolizumab-Ilto | Injectable; Injection | SUPPL-1 | Galderma Labs Lp | Labeling | Approved |
| Phexxi
NDA #208352 |
Citric Acid; Lactic Acid; Potassium Bitartrate | Gel; Vaginal | SUPPL-5 | Evofem Inc | Labeling | Approved |
| Phexxi
NDA #208352 |
Citric Acid; Lactic Acid; Potassium Bitartrate | Gel; Vaginal | SUPPL-5 | Evofem Inc | Labeling | Approved |
| Potassium Chloride
ANDA #205549 |
Potassium Chloride | Capsule, Extended Release; Oral | SUPPL-1 | Strides Pharma | Labeling | Approved |
| Zidovudine
ANDA #078128 |
Zidovudine | Capsule; Oral | SUPPL-18 | Aurobindo Pharma Ltd | Labeling | Approved |
| Zidovudine
ANDA #078128 |
Zidovudine | Capsule; Oral | SUPPL-22 | Aurobindo Pharma Ltd | Labeling | Approved |
April 18, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bkemv
BLA #761333 |
Eculizumab-Aeeb | Injectable; Injection | SUPPL-4 | Amgen Inc | REMS | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-37 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-37 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-40 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-37 | Sciegen Pharms Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #205794 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-40 | Sciegen Pharms Inc | Labeling | Approved |
| Colesevelam Hydrochloride
ANDA #204893 |
Colesevelam Hydrochloride | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Fesoterodine Fumarate
ANDA #204893 |
Fesoterodine Fumarate | Tablet, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Memantine Hydrochloride
ANDA #206032 |
Memantine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-6 | Rising | Manufacturing (CMC) | Approved |
| Memantine Hydrochloride
ANDA #206032 |
Memantine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-6 | Rising | Manufacturing (CMC) | Approved |
| Neupogen
BLA #103353 |
Filgrastim | Syringe | SUPPL-5201 | Amgen | Labeling | Approved |
| Neupogen
BLA #103353 |
Filgrastim | Vial | SUPPL-5201 | Amgen | Labeling | Approved |
| Ojjaara
NDA #216873 |
Momelotinib Dihydrochloride | Tablet; Oral | SUPPL-2 | Glaxosmithkline | Labeling | Approved |
| Prednisolone Sodium Phosphate
ANDA #076913 |
Prednisolone Sodium Phosphate | Solution; Oral | SUPPL-16 | Pharm Assoc | Manufacturing (CMC) | Approved |
| Prednisolone Sodium Phosphate
ANDA #076913 |
Prednisolone Sodium Phosphate | Solution; Oral | SUPPL-16 | Pharm Assoc | Manufacturing (CMC) | Approved |
| Simponi
BLA #125289 |
Golimumab | Injectable; Injection | SUPPL-155 | Centocor Ortho Biotech Inc | Labeling | Approved |
| Simponi Aria
BLA #125433 |
Golimumab | Injectable; Injection | SUPPL-36 | Janssen Biotech | Labeling | Approved |
| Voriconazole
NDA #208562 |
Voriconazole | Injectable; Injection | SUPPL-11 | Hikma | Labeling | Approved |
| Voriconazole
NDA #208562 |
Voriconazole | Injectable; Intravenous | SUPPL-11 | Hikma | Labeling | Approved |
| Wainua (Autoinjector)
NDA #217388 |
Eplontersen Sodium | Solution; Subcutaneous | SUPPL-4 | Astrazeneca Ab | Labeling | Approved |
| Wainua (Autoinjector)
NDA #217388 |
Eplontersen Sodium | Solution; Subcutaneous | SUPPL-4 | Astrazeneca Ab | Labeling | Approved |
April 17, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Axitinib
ANDA #211650 |
Axitinib | Tablet; Oral | ORIG-1 | Apotex Inc | Tentative Approval | |
| Camzyos
NDA #214998 |
Mavacamten | Capsule; Oral | SUPPL-10 | Bristol | Efficacy | Approved |
| Children's Claritin
NDA #021891 |
Loratadine | Tablet, Chewable; Oral | SUPPL-46 | Bayer Healthcare Llc | Manufacturing (CMC) | Approved |
| Claritin
NDA #019658 |
Loratadine | Tablet; Oral | SUPPL-62 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin
NDA #021891 |
Loratadine | Tablet, Chewable; Oral | SUPPL-46 | Bayer Healthcare Llc | Manufacturing (CMC) | Approved |
| Claritin Hives Relief
NDA #019658 |
Loratadine | Tablet; Oral | SUPPL-62 | Bayer Healthcare Llc | Labeling | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205128 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | SUPPL-2 | Actavis Labs Ut Inc | Labeling | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205128 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | SUPPL-2 | Actavis Labs Ut Inc | Labeling | Approved |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-51 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Eliquis
NDA #202155 |
Apixaban | Tablet; Oral | SUPPL-40 | Bristol Myers Squibb | Efficacy | Approved |
| Eliquis
NDA #202155 |
Apixaban | Tablet; Oral | SUPPL-39 | Bristol Myers Squibb | Efficacy | Approved |
| Eliquis
NDA #220073 |
Apixaban | Suspension; Oral | ORIG-1 | Bristol Myers Squibb | Type 3 - New Dosage Form | Approved |
| Eliquis
NDA #220073 |
Apixaban | Tablet; Oral | ORIG-1 | Bristol Myers Squibb | Type 3 - New Dosage Form | Approved |
| Esomeprazole Sodium
ANDA #205379 |
Esomeprazole Sodium | Injectable; Intravenous | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Esomeprazole Sodium
ANDA #205379 |
Esomeprazole Sodium | Injectable; Intravenous | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
ANDA #215232 |
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Linezolid
ANDA #206454 |
Linezolid | Solution; Intravenous | SUPPL-3 | Hikma | Labeling | Approved |
| Nicardipine Hydrochloride
ANDA #074928 |
Nicardipine Hydrochloride | Capsule; Oral | SUPPL-8 | Epic Pharma Llc | Labeling | Approved |
| Olmesartan Medoxomil
ANDA #205482 |
Olmesartan Medoxomil | Tablet; Oral | SUPPL-8 | Jubilant Generics | Labeling | Approved |
| Pantoprazole Sodium
ANDA #077674 |
Pantoprazole Sodium | Injectable; Intravenous | SUPPL-12 | Sun Pharm | Labeling | Approved |
| Pantoprazole Sodium
ANDA #077674 |
Pantoprazole Sodium | Injectable; Intravenous | SUPPL-15 | Sun Pharm | Labeling | Approved |
April 16, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abacavir Sulfate and Lamivudine
ANDA #205412 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
| Bisoprolol Fumarate
ANDA #219044 |
Bisoprolol Fumarate | Tablet; Oral | ORIG-1 | Unique Pharm | Approved | |
| Carbamazepine
ANDA #216623 |
Carbamazepine | Tablet; Oral | ORIG-1 | Alembic | Approved | |
| Cardizem
NDA #018602 |
Diltiazem Hydrochloride | Tablet; Oral | SUPPL-72 | Bausch | Labeling | Approved |
| Cardizem Cd
NDA #020062 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-48 | Bausch | Labeling | Approved |
| Cardizem La
NDA #021392 |
Diltiazem Hydrochloride | Tablet, Extended Release; Oral | SUPPL-25 | Bausch | Labeling | Approved |
| Cardizem La
NDA #021392 |
Diltiazem Hydrochloride | Tablet, Extended Release; Oral | SUPPL-28 | Bausch | Labeling | Approved |
| Dexmedetomidine Hydrochloride
ANDA #206407 |
Dexmedetomidine Hydrochloride | Injectable; Injection | SUPPL-6 | Hikma | Labeling | Approved |
| Dexmedetomidine Hydrochloride
ANDA #206407 |
Dexmedetomidine Hydrochloride | Injectable; Injection | SUPPL-7 | Hikma | Labeling | Approved |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-72 | Regeneron Pharmaceuticals | Labeling | Approved |
| Frovatriptan Succinate
ANDA #216998 |
Frovatriptan Succinate | Tablet; Oral | ORIG-1 | Leading | Approved | |
| Gadobutrol
ANDA #217480 |
Gadobutrol | Solution; Intravenous | SUPPL-4 | Hainan Poly Pharm | Manufacturing (CMC) | Approved |
| Gadobutrol
ANDA #217480 |
Gadobutrol | Solution; Intravenous | SUPPL-4 | Hainan Poly Pharm | Manufacturing (CMC) | Approved |
| Mesalamine
ANDA #215269 |
Mesalamine | Enema; Rectal | ORIG-1 | Novitium Pharma | Approved | |
| Methylprednisolone Acetate
ANDA #219145 |
Methylprednisolone Acetate | Injectable; Injection | ORIG-1 | Hikma | Approved | |
| Montelukast Sodium
ANDA #205107 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-1 | Amneal Pharms | Labeling | Approved |
| Posfrea
NDA #203050 |
Palonosetron Hydrochloride | Solution; Intravenous | SUPPL-3 | Avyxa Holdings | Efficacy | Approved |
| Tiazac
NDA #020401 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-44 | Bausch | Labeling | Approved |
| Valganciclovir Hydrochloride
ANDA #218027 |
Valganciclovir Hydrochloride | Tablet; Oral | ORIG-1 | Sph Zhongxi Pharm | Approved |
April 15, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Almotriptan Malate
ANDA #205171 |
Almotriptan Malate | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Almotriptan Malate
ANDA #205171 |
Almotriptan Malate | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Carbidopa, Levodopa and Entacapone
ANDA #214495 |
Carbidopa; Entacapone; Levodopa | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Divalproex Sodium
ANDA #215527 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-2 | Annora Pharma | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #218948 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Esomeprazole Magnesium
ANDA #219213 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-21 | Perrigo R and D | Manufacturing (CMC) | Approved |
| Guanfacine Hydrochloride
ANDA #219689 |
Guanfacine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Rubicon | Approved | |
| Isturisa
NDA #212801 |
Osilodrostat Phosphate | Tablet; Oral | SUPPL-3 | Recordati Rare | Efficacy | Approved |
| Lurasidone Hydrochloride
ANDA #208031 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208031 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Mezofy
NDA #211448 |
Aripiprazole | Film; Oral | ORIG-1 | Cmg Pharmaceutical Co Ltd | Type 3 - New Dosage Form | Approved |
| Nitazoxanide
ANDA #218701 |
Nitazoxanide | Tablet; Oral | ORIG-1 | Annora Pharma | Approved | |
| Nitroglycerin
ANDA #218235 |
Nitroglycerin | Ointment; Transdermal | ORIG-1 | Encube | Approved | |
| Pataday Once Daily Relief
NDA #021545 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-29 | Alcon Labs Inc | Labeling | Approved |
| Pataday Once Daily Relief
NDA #206276 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-11 | Alcon Labs Inc | Labeling | Approved |
| Pataday Twice Daily Relief
NDA #020688 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-37 | Alcon Labs Inc | Labeling | Approved |
| Ranolazine
ANDA #211361 |
Ranolazine | Tablet, Extended Release; Oral | ORIG-1 | Jubilant Generics | Approved | |
| Rufinamide
ANDA #214817 |
Rufinamide | Suspension; Oral | ORIG-1 | Msn | Approved | |
| Ticagrelor
ANDA #208508 |
Ticagrelor | Tablet; Oral | SUPPL-6 | Sunshine | Labeling | Approved |
| Valtoco
NDA #211635 |
Diazepam | Spray; Nasal | SUPPL-10 | Neurelis Inc | Efficacy | Approved |
| Welireg
NDA #215383 |
Belzutifan | Tablet; Oral | SUPPL-10 | Merck Sharp Dohme | Efficacy | Approved |
| Welireg
NDA #215383 |
Belzutifan | Tablet; Oral | SUPPL-11 | Merck Sharp Dohme | Efficacy | Approved |
April 14, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
ANDA #204209 |
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate | Tablet; Oral | SUPPL-14 | Larken Labs Inc | Labeling | Approved |
| Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
ANDA #204209 |
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate | Tablet; Oral | SUPPL-14 | Larken Labs Inc | Labeling | Approved |
| Allopurinol
ANDA #215091 |
Allopurinol | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Digoxin
NDA #021648 |
Digoxin | Elixir; Oral | SUPPL-13 | Hikma | Labeling | Approved |
| Doxorubicin Hydrochloride (Liposomal)
ANDA #203263 |
Doxorubicin Hydrochloride | Injectable, Liposomal; Injection | SUPPL-38 | Sun Pharm | Labeling | Approved |
| Doxorubicin Hydrochloride (Liposomal)
ANDA #203263 |
Doxorubicin Hydrochloride | Injectable, Liposomal; Injection | SUPPL-38 | Sun Pharm | Labeling | Approved |
| Imatinib Mesylate
ANDA #212975 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
| Latanoprost
ANDA #219306 |
Latanoprost | Solution/Drops; Ophthalmic | ORIG-1 | Micro Labs | Approved | |
| Mesalamine
ANDA #219028 |
Mesalamine | Suppository; Rectal | ORIG-1 | Rising | Approved | |
| Metformin Hydrochloride
ANDA #219151 |
Metformin Hydrochloride | Solution; Oral | ORIG-1 | Bionpharma | Approved | |
| Moxifloxacin Hydrochloride
ANDA #205348 |
Moxifloxacin Hydrochloride | Tablet; Oral | SUPPL-6 | Crossmedika Sa | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #205348 |
Moxifloxacin Hydrochloride | Tablet; Oral | SUPPL-6 | Crossmedika Sa | Labeling | Approved |
| Otulfi
BLA #761379 |
Ustekinumab-Aauz | Injectable; Injection | SUPPL-1 | Fresenius Kabi Usa | Labeling | Approved |
| Otulfi
BLA #761379 |
Ustekinumab-Aauz | Injectable; Injection | SUPPL-1 | Fresenius Kabi Usa | Labeling | Approved |
| Otulfi
BLA #761379 |
Ustekinumab-Aauz | Injectable; Injection | SUPPL-1 | Fresenius Kabi Usa | Labeling | Approved |
| Sucralfate
ANDA #211780 |
Sucralfate | Suspension; Oral | ORIG-1 | Padagis Us | Approved | |
| Zinc Chloride
ANDA #217625 |
Zinc Chloride | Injectable; Injection | ORIG-1 | Stira | Approved |