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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
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