Drugs@FDA: FDA-Approved Drugs
Recent New and Generic Drug Approvals
This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
June 10, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Argatroban In Sodium Chloride
NDA #022434 |
Argatroban | Injectable; Intravenous | SUPPL-14 | Cipla | Labeling | Approved |
| Argatroban In Sodium Chloride
NDA #209552 |
Argatroban | Solution; Intravenous | SUPPL-8 | Eugia Pharma Speclts | Labeling | Approved |
| Clindamycin Phosphate
ANDA #064050 |
Clindamycin Phosphate | Solution; Topical | SUPPL-28 | Padagis Us | Labeling | Approved |
| Dorzolamide Hydrochloride
ANDA #205294 |
Dorzolamide Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-8 | Fdc Ltd | Labeling | Approved |
| Dorzolamide Hydrochloride
ANDA #205294 |
Dorzolamide Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-8 | Fdc Ltd | Labeling | Approved |
| Doxylamine Succinate and Pyridoxine Hydrochloride
ANDA #207825 |
Doxylamine Succinate; Pyridoxine Hydrochloride | Tablet, Delayed Release; Oral | SUPPL-1 | Pharmobedient | Labeling | Approved |
| Doxylamine Succinate and Pyridoxine Hydrochloride
ANDA #207825 |
Doxylamine Succinate; Pyridoxine Hydrochloride | Tablet, Delayed Release; Oral | SUPPL-1 | Pharmobedient | Labeling | Approved |
| Exdensur
BLA #761458 |
Depemokimab-Ulaa | Injection | SUPPL-2 | Glaxosmithkline Llc | Labeling | Approved |
| Fluorescite
NDA #021980 |
Fluorescein Sodium | Injectable; Intravenous | SUPPL-12 | Alcon Labs Inc | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #212143 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-4 | Chia Tai Tianqing | Labeling | Approved |
| Malarone
NDA #021078 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-26 | Glaxosmithkline | Labeling | Approved |
| Malarone Pediatric
NDA #021078 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-26 | Glaxosmithkline | Labeling | Approved |
| Propranolol Hydrochloride
ANDA #219165 |
Propranolol Hydrochloride | Solution; Oral | ORIG-1 | Pai Holdings | Approved | |
| Terlivaz
NDA #022231 |
Terlipressin Acetate | Powder; Intravenous | SUPPL-4 | Mallinckrodt Ireland | Labeling | Approved |
| Valacyclovir Hydrochloride
ANDA #203047 |
Valacyclovir Hydrochloride | Tablet; Oral | SUPPL-20 | Hetero Labs Ltd V | Labeling | Approved |
| Voranigo
NDA #218784 |
Vorasidenib | Tablet; Oral | SUPPL-4 | Servier | Labeling | Approved |
June 9, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
ANDA #204949 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-4 | Pharmobedient | Labeling | Approved |
| Azacitidine
ANDA #204949 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-6 | Pharmobedient | Labeling | Approved |
| Azacitidine
ANDA #204949 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-7 | Pharmobedient | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-6 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-12 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-2 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-6 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-11 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Cephalexin
ANDA #213568 |
Cephalexin | For Suspension; Oral | ORIG-1 | Aurobindo Pharma | Approved | |
| Ebglyss
BLA #761306 |
Lebrikizumab-Lbkz | Injectable; Injection | SUPPL-6 | Eli Lilly and Co | Efficacy | Approved |
| Linezolid In Sodium Chloride 0.9% In Plastic Container
NDA #206473 |
Linezolid | Solution; Intravenous | SUPPL-13 | Hospira | Labeling | Approved |
| Tofacitinib Citrate
ANDA #215552 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Yaopharma Co Ltd | Approved | |
| Tofacitinib Citrate
ANDA #218821 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Concord Biotech Ltd | Approved | |
| Tofacitinib Citrate
ANDA #218900 |
Tofacitinib Citrate | Solution; Oral | ORIG-1 | Saptalis Pharms | Approved | |
| Tofacitinib Citrate
ANDA #219370 |
Tofacitinib Citrate | Solution; Oral | ORIG-1 | Auson | Approved | |
| Tofacitinib Citrate
ANDA #219830 |
Tofacitinib Citrate | Tablet, Extended Release; Oral | ORIG-1 | Orient Pharma | Approved | |
| Tofacitinib Citrate
ANDA #219830 |
Tofacitinib Citrate | Tablet, Extended Release; Oral | ORIG-2 | Orient Pharma | Tentative Approval | |
| Vancomycin Hydrochloride In Plastic Container
NDA #050671 |
Vancomycin Hydrochloride | Solution; Intravenous | SUPPL-43 | Baxter Hlthcare | Labeling | Approved |
| Zyvox
NDA #021130 |
Linezolid | Tablet; Oral | SUPPL-50 | Pfizer | Labeling | Approved |
| Zyvox
NDA #021131 |
Linezolid | Solution; Intravenous | SUPPL-48 | Pfizer | Labeling | Approved |
| Zyvox
NDA #021132 |
Linezolid | For Suspension; Oral | SUPPL-50 | Pfizer | Labeling | Approved |
June 8, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alendronate Sodium
ANDA #076584 |
Alendronate Sodium | Tablet; Oral | SUPPL-18 | Rising | Labeling | Approved |
| Atovaquone
ANDA #209685 |
Atovaquone | Suspension; Oral | SUPPL-10 | Glenmark Speclt | Labeling | Approved |
| Atovaquone
ANDA #210692 |
Atovaquone | Suspension; Oral | SUPPL-6 | Hetero Labs Ltd Iii | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-30 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-34 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-38 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-30 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-34 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-38 | Mylan Technologies | Labeling | Approved |
| Gadobutrol
ANDA #219146 |
Gadobutrol | Solution; Intravenous | ORIG-1 | Zenara | Approved | |
| Gallium Ga 68 Gozetotide
ANDA #216410 |
Gallium Ga-68 Gozetotide | Solution; Intravenous | ORIG-1 | Radiomedix | Approved | |
| Irbesartan and Hydrochlorothiazide
ANDA #077446 |
Hydrochlorothiazide; Irbesartan | Tablet; Oral | SUPPL-15 | Sandoz | Labeling | Approved |
| Labetalol Hydrochloride
ANDA #212990 |
Labetalol Hydrochloride | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-1 | Aiping Pharm Inc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-3 | Aiping Pharm Inc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-1 | Aiping Pharm Inc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-3 | Aiping Pharm Inc | Labeling | Approved |
| Losartan Potassium
ANDA #078232 |
Losartan Potassium | Tablet; Oral | SUPPL-44 | Lupin Ltd | Labeling | Approved |
| Losartan Potassium
ANDA #078232 |
Losartan Potassium | Tablet; Oral | SUPPL-44 | Lupin Ltd | Labeling | Approved |
| Losartan Potassium
ANDA #090382 |
Losartan Potassium | Tablet; Oral | SUPPL-38 | Strides Pharma | Labeling | Approved |
| Macitentan
ANDA #211000 |
Macitentan | Tablet; Oral | ORIG-1 | Amneal | Approved | |
| Macitentan
ANDA #211187 |
Macitentan | Tablet; Oral | ORIG-1 | Teva Pharms Usa Inc | Approved | |
| Opdualag
BLA #761234 |
Nivolumab;Relatlimab-Rmbw | Solution; Intravenous | SUPPL-11 | Bristol Myers Squibb | Labeling | Approved |
| Oxcarbazepine
ANDA #078005 |
Oxcarbazepine | Tablet; Oral | SUPPL-12 | Ani Pharms | Labeling | Approved |
| Oxcarbazepine
ANDA #078005 |
Oxcarbazepine | Tablet; Oral | SUPPL-15 | Ani Pharms | Labeling | Approved |
| Risedronate Sodium
ANDA #077132 |
Risedronate Sodium | Tablet; Oral | SUPPL-13 | Teva Pharms Usa | Labeling | Approved |
| Risedronate Sodium
ANDA #077132 |
Risedronate Sodium | Tablet; Oral | SUPPL-13 | Teva Pharms Usa | Labeling | Approved |
| Risedronate Sodium
ANDA #200296 |
Risedronate Sodium | Tablet; Oral | SUPPL-8 | Aurobindo Pharma Ltd | Labeling | Approved |
| Risedronate Sodium
ANDA #200296 |
Risedronate Sodium | Tablet; Oral | SUPPL-8 | Aurobindo Pharma Ltd | Labeling | Approved |
| Risperidone
ANDA #077494 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-27 | Ph Health | Labeling | Approved |
| Risperidone
ANDA #077494 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-27 | Ph Health | Labeling | Approved |
| Succinylcholine Chloride
ANDA #217873 |
Succinylcholine Chloride | Solution; Intramuscular, Intravenous | SUPPL-3 | Steriscience | Labeling | Approved |
June 6, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Provocholine
NDA #019193 |
Methacholine Chloride | For Solution; Inhalation | SUPPL-32 | Methapharm | Labeling | Approved |
June 10, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Argatroban In Sodium Chloride
NDA #022434 |
Argatroban | Injectable; Intravenous | SUPPL-14 | Cipla | Labeling | Approved |
| Argatroban In Sodium Chloride
NDA #209552 |
Argatroban | Solution; Intravenous | SUPPL-8 | Eugia Pharma Speclts | Labeling | Approved |
| Clindamycin Phosphate
ANDA #064050 |
Clindamycin Phosphate | Solution; Topical | SUPPL-28 | Padagis Us | Labeling | Approved |
| Dorzolamide Hydrochloride
ANDA #205294 |
Dorzolamide Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-8 | Fdc Ltd | Labeling | Approved |
| Dorzolamide Hydrochloride
ANDA #205294 |
Dorzolamide Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-8 | Fdc Ltd | Labeling | Approved |
| Doxylamine Succinate and Pyridoxine Hydrochloride
ANDA #207825 |
Doxylamine Succinate; Pyridoxine Hydrochloride | Tablet, Delayed Release; Oral | SUPPL-1 | Pharmobedient | Labeling | Approved |
| Doxylamine Succinate and Pyridoxine Hydrochloride
ANDA #207825 |
Doxylamine Succinate; Pyridoxine Hydrochloride | Tablet, Delayed Release; Oral | SUPPL-1 | Pharmobedient | Labeling | Approved |
| Exdensur
BLA #761458 |
Depemokimab-Ulaa | Injection | SUPPL-2 | Glaxosmithkline Llc | Labeling | Approved |
| Fluorescite
NDA #021980 |
Fluorescein Sodium | Injectable; Intravenous | SUPPL-12 | Alcon Labs Inc | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #212143 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-4 | Chia Tai Tianqing | Labeling | Approved |
| Malarone
NDA #021078 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-26 | Glaxosmithkline | Labeling | Approved |
| Malarone Pediatric
NDA #021078 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-26 | Glaxosmithkline | Labeling | Approved |
| Propranolol Hydrochloride
ANDA #219165 |
Propranolol Hydrochloride | Solution; Oral | ORIG-1 | Pai Holdings | Approved | |
| Terlivaz
NDA #022231 |
Terlipressin Acetate | Powder; Intravenous | SUPPL-4 | Mallinckrodt Ireland | Labeling | Approved |
| Valacyclovir Hydrochloride
ANDA #203047 |
Valacyclovir Hydrochloride | Tablet; Oral | SUPPL-20 | Hetero Labs Ltd V | Labeling | Approved |
| Voranigo
NDA #218784 |
Vorasidenib | Tablet; Oral | SUPPL-4 | Servier | Labeling | Approved |
June 9, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
ANDA #204949 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-4 | Pharmobedient | Labeling | Approved |
| Azacitidine
ANDA #204949 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-6 | Pharmobedient | Labeling | Approved |
| Azacitidine
ANDA #204949 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-7 | Pharmobedient | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-6 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-12 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-2 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-6 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-10 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-11 | Accord Hlthcare | Labeling | Approved |
| Capecitabine
ANDA #202593 |
Capecitabine | Tablet; Oral | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Cephalexin
ANDA #213568 |
Cephalexin | For Suspension; Oral | ORIG-1 | Aurobindo Pharma | Approved | |
| Ebglyss
BLA #761306 |
Lebrikizumab-Lbkz | Injectable; Injection | SUPPL-6 | Eli Lilly and Co | Efficacy | Approved |
| Linezolid In Sodium Chloride 0.9% In Plastic Container
NDA #206473 |
Linezolid | Solution; Intravenous | SUPPL-13 | Hospira | Labeling | Approved |
| Tofacitinib Citrate
ANDA #215552 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Yaopharma Co Ltd | Approved | |
| Tofacitinib Citrate
ANDA #218821 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Concord Biotech Ltd | Approved | |
| Tofacitinib Citrate
ANDA #218900 |
Tofacitinib Citrate | Solution; Oral | ORIG-1 | Saptalis Pharms | Approved | |
| Tofacitinib Citrate
ANDA #219370 |
Tofacitinib Citrate | Solution; Oral | ORIG-1 | Auson | Approved | |
| Tofacitinib Citrate
ANDA #219830 |
Tofacitinib Citrate | Tablet, Extended Release; Oral | ORIG-1 | Orient Pharma | Approved | |
| Tofacitinib Citrate
ANDA #219830 |
Tofacitinib Citrate | Tablet, Extended Release; Oral | ORIG-2 | Orient Pharma | Tentative Approval | |
| Vancomycin Hydrochloride In Plastic Container
NDA #050671 |
Vancomycin Hydrochloride | Solution; Intravenous | SUPPL-43 | Baxter Hlthcare | Labeling | Approved |
| Zyvox
NDA #021130 |
Linezolid | Tablet; Oral | SUPPL-50 | Pfizer | Labeling | Approved |
| Zyvox
NDA #021131 |
Linezolid | Solution; Intravenous | SUPPL-48 | Pfizer | Labeling | Approved |
| Zyvox
NDA #021132 |
Linezolid | For Suspension; Oral | SUPPL-50 | Pfizer | Labeling | Approved |
June 8, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alendronate Sodium
ANDA #076584 |
Alendronate Sodium | Tablet; Oral | SUPPL-18 | Rising | Labeling | Approved |
| Atovaquone
ANDA #209685 |
Atovaquone | Suspension; Oral | SUPPL-10 | Glenmark Speclt | Labeling | Approved |
| Atovaquone
ANDA #210692 |
Atovaquone | Suspension; Oral | SUPPL-6 | Hetero Labs Ltd Iii | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-30 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-34 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-38 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-30 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-34 | Mylan Technologies | Labeling | Approved |
| Estradiol
ANDA #075182 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-38 | Mylan Technologies | Labeling | Approved |
| Gadobutrol
ANDA #219146 |
Gadobutrol | Solution; Intravenous | ORIG-1 | Zenara | Approved | |
| Gallium Ga 68 Gozetotide
ANDA #216410 |
Gallium Ga-68 Gozetotide | Solution; Intravenous | ORIG-1 | Radiomedix | Approved | |
| Irbesartan and Hydrochlorothiazide
ANDA #077446 |
Hydrochlorothiazide; Irbesartan | Tablet; Oral | SUPPL-15 | Sandoz | Labeling | Approved |
| Labetalol Hydrochloride
ANDA #212990 |
Labetalol Hydrochloride | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-1 | Aiping Pharm Inc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-3 | Aiping Pharm Inc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-1 | Aiping Pharm Inc | Labeling | Approved |
| Levetiracetam
ANDA #204754 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-3 | Aiping Pharm Inc | Labeling | Approved |
| Losartan Potassium
ANDA #078232 |
Losartan Potassium | Tablet; Oral | SUPPL-44 | Lupin Ltd | Labeling | Approved |
| Losartan Potassium
ANDA #078232 |
Losartan Potassium | Tablet; Oral | SUPPL-44 | Lupin Ltd | Labeling | Approved |
| Losartan Potassium
ANDA #090382 |
Losartan Potassium | Tablet; Oral | SUPPL-38 | Strides Pharma | Labeling | Approved |
| Macitentan
ANDA #211000 |
Macitentan | Tablet; Oral | ORIG-1 | Amneal | Approved | |
| Macitentan
ANDA #211187 |
Macitentan | Tablet; Oral | ORIG-1 | Teva Pharms Usa Inc | Approved | |
| Opdualag
BLA #761234 |
Nivolumab;Relatlimab-Rmbw | Solution; Intravenous | SUPPL-11 | Bristol Myers Squibb | Labeling | Approved |
| Oxcarbazepine
ANDA #078005 |
Oxcarbazepine | Tablet; Oral | SUPPL-12 | Ani Pharms | Labeling | Approved |
| Oxcarbazepine
ANDA #078005 |
Oxcarbazepine | Tablet; Oral | SUPPL-15 | Ani Pharms | Labeling | Approved |
| Risedronate Sodium
ANDA #077132 |
Risedronate Sodium | Tablet; Oral | SUPPL-13 | Teva Pharms Usa | Labeling | Approved |
| Risedronate Sodium
ANDA #077132 |
Risedronate Sodium | Tablet; Oral | SUPPL-13 | Teva Pharms Usa | Labeling | Approved |
| Risedronate Sodium
ANDA #200296 |
Risedronate Sodium | Tablet; Oral | SUPPL-8 | Aurobindo Pharma Ltd | Labeling | Approved |
| Risedronate Sodium
ANDA #200296 |
Risedronate Sodium | Tablet; Oral | SUPPL-8 | Aurobindo Pharma Ltd | Labeling | Approved |
| Risperidone
ANDA #077494 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-27 | Ph Health | Labeling | Approved |
| Risperidone
ANDA #077494 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-27 | Ph Health | Labeling | Approved |
| Succinylcholine Chloride
ANDA #217873 |
Succinylcholine Chloride | Solution; Intramuscular, Intravenous | SUPPL-3 | Steriscience | Labeling | Approved |
June 6, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Provocholine
NDA #019193 |
Methacholine Chloride | For Solution; Inhalation | SUPPL-32 | Methapharm | Labeling | Approved |
June 5, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abiraterone Acetate
ANDA #208371 |
Abiraterone Acetate | Tablet; Oral | SUPPL-5 | Rising | Labeling | Approved |
| Acetazolamide Sodium
ANDA #202693 |
Acetazolamide Sodium | Injectable; Injection | SUPPL-12 | Avet Lifesciences | Labeling | Approved |
| Acyclovir
ANDA #075211 |
Acyclovir | Tablet; Oral | SUPPL-16 | Aurobindo Pharma Usa | Labeling | Approved |
| Ajovy
BLA #761089 |
Fremanezumab-Vfrm | Injectable; Injection | SUPPL-36 | Teva Pharms Usa | Labeling | Approved |
| Brimonidine Tartrate
ANDA #216772 |
Brimonidine Tartrate | Solution/Drops; Ophthalmic | SUPPL-2 | Upsher Smith Labs | Labeling | Approved |
| Brimonidine Tartrate
ANDA #216772 |
Brimonidine Tartrate | Solution/Drops; Ophthalmic | SUPPL-2 | Upsher Smith Labs | Labeling | Approved |
| Dabigatran Etexilate Mesylate
ANDA #207961 |
Dabigatran Etexilate Mesylate | Capsule; Oral | SUPPL-13 | Hetero Labs Ltd Iii | Labeling | Approved |
| Emgality
BLA #761063 |
Galcanezumab-Gnlm | Injectable; Injection | SUPPL-13 | Eli Lilly and Co | Labeling | Approved |
| Emgality
BLA #761063 |
Galcanezumab-Gnlm | Injectable; Injection | SUPPL-13 | Eli Lilly and Co | Labeling | Approved |
| Epidiolex
NDA #210365 |
Cannabidiol | Solution; Oral | SUPPL-24 | Jazz Pharms Res | Labeling | Approved |
| Epidiolex
NDA #210365 |
Cannabidiol | Solution; Oral | SUPPL-29 | Jazz Pharms Res | Labeling | Approved |
| Epidiolex
NDA #210365 |
Cannabidiol | Solution; Oral | SUPPL-30 | Jazz Pharms Res | Labeling | Approved |
| Epidiolex
NDA #210365 |
Cannabidiol | Solution; Oral | SUPPL-24 | Jazz Pharms Res | Labeling | Approved |
| Epidiolex
NDA #210365 |
Cannabidiol | Solution; Oral | SUPPL-29 | Jazz Pharms Res | Labeling | Approved |
| Epidiolex
NDA #210365 |
Cannabidiol | Solution; Oral | SUPPL-30 | Jazz Pharms Res | Labeling | Approved |
| Hympavzi
BLA #761369 |
Marstacimab-Hncq | Injectable; Subcutaneous | SUPPL-3 | Pfizer Inc | Efficacy | Approved |
| Imuldosa
BLA #761364 |
Ustekinumab-Srlf | Injectable; Intravenous | SUPPL-5 | Accord Biopharma Inc. | Bioequivalence | Approved |
| Lidocaine Hydrochloride
ANDA #040078 |
Lidocaine Hydrochloride | Injectable; Injection | SUPPL-38 | Hospira | Labeling | Approved |
| Rabeprazole Sodium
ANDA #204237 |
Rabeprazole Sodium | Tablet, Delayed Release; Oral | SUPPL-18 | Rubicon Research | Labeling | Approved |
| Sotalol Hydrochloride
ANDA #207429 |
Sotalol Hydrochloride | Tablet; Oral | SUPPL-8 | Regcon Holdings | Labeling | Approved |
| Tofacitinib Citrate
ANDA #209829 |
Tofacitinib Citrate | Tablet; Oral | ORIG-2 | Zydus Pharms | Approved | |
| Vyepti
BLA #761119 |
Eptinezumab-Jjmr | Injectable; Injection | SUPPL-15 | Lundbeck Seattle Biopharmaceuticals, Inc. | Labeling | Approved |
June 4, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cangrelor
ANDA #213703 |
Cangrelor | Powder; Intravenous | ORIG-1 | Msn | Approved | |
| Children's Allegra Allergy
NDA #021909 |
Fexofenadine Hydrochloride | Tablet, Orally Disintegrating; Oral | SUPPL-19 | Chattem Sanofi | Labeling | Approved |
| Children's Allegra Hives
NDA #021909 |
Fexofenadine Hydrochloride | Tablet, Orally Disintegrating; Oral | SUPPL-19 | Chattem Sanofi | Labeling | Approved |
| Dalbavancin Hydrochloride
ANDA #219604 |
Dalbavancin Hydrochloride | Powder; Intravenous | ORIG-1 | Be Pharms | Approved | |
| Dipyridamole
ANDA #074521 |
Dipyridamole | Injectable; Injection | SUPPL-25 | Hikma | Manufacturing (CMC) | Approved |
| Dipyridamole
ANDA #074521 |
Dipyridamole | Injectable; Injection | SUPPL-25 | Hikma | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #214470 |
Haloperidol | Tablet; Oral | ORIG-1 | Alembic | Approved | |
| Ramelteon
ANDA #215243 |
Ramelteon | Tablet; Oral | SUPPL-4 | Micro Labs | Manufacturing (CMC) | Approved |
| Ramelteon
ANDA #215243 |
Ramelteon | Tablet; Oral | SUPPL-4 | Micro Labs | Manufacturing (CMC) | Approved |
| Ramelteon
ANDA #215243 |
Ramelteon | Tablet; Oral | SUPPL-4 | Micro Labs | Manufacturing (CMC) | Approved |
| Ramelteon
ANDA #215485 |
Ramelteon | Tablet; Oral | ORIG-1 | Hibrow Hlthcare | Approved |
June 3, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Argatroban In Dextrose
NDA #201743 |
Argatroban | Solution; Intravenous | SUPPL-3 | Sandoz | Labeling | Approved |
| Azelastine Hydrochloride and Fluticasone Propionate
ANDA #208111 |
Azelastine Hydrochloride; Fluticasone Propionate | Spray, Metered; Nasal | SUPPL-11 | Padagis Israel | Labeling | Approved |
| Brenzavvy
NDA #214373 |
Bexagliflozin | Tablet; Oral | SUPPL-2 | Theracosbio | Labeling | Approved |
| Brenzavvy
NDA #214373 |
Bexagliflozin | Tablet; Oral | SUPPL-2 | Theracosbio | Labeling | Approved |
| Dextromethorphan Hydrobromide and Quinidine Sulfate
ANDA #204196 |
Dextromethorphan Hydrobromide; Quinidine Sulfate | Capsule; Oral | ORIG-1 | Sun Pharm | Approved | |
| Farxiga
NDA #202293 |
Dapagliflozin | Tablet; Oral | SUPPL-35 | Astrazeneca Ab | Labeling | Approved |
| Invokana
NDA #204042 |
Canagliflozin | Tablet; Oral | SUPPL-44 | Janssen Pharms | Labeling | Approved |
| Qtern
NDA #209091 |
Dapagliflozin; Saxagliptin Hydrochloride | Tablet; Oral | SUPPL-9 | Astrazeneca Ab | Labeling | Approved |
| Sertraline Hydrochloride
ANDA #077345 |
Sertraline Hydrochloride | Tablet; Oral | SUPPL-14 | Heritage Pharma Avet | Labeling | Approved |
| Sertraline Hydrochloride
ANDA #077345 |
Sertraline Hydrochloride | Tablet; Oral | SUPPL-14 | Heritage Pharma Avet | Labeling | Approved |
| Steglatro
NDA #209803 |
Ertugliflozin | Tablet; Oral | SUPPL-12 | Msd Sub Merck | Labeling | Approved |
| Steglatro
NDA #209803 |
Ertugliflozin | Tablet; Oral | SUPPL-12 | Msd Sub Merck | Labeling | Approved |
| Steglujan
NDA #209805 |
Ertugliflozin; Sitagliptin Phosphate | Tablet; Oral | SUPPL-22 | Msd Sub Merck | Labeling | Approved |
| Tofacitinib Citrate
ANDA #209633 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Breckenridge | Approved | |
| Tofacitinib Citrate
ANDA #209738 |
Tofacitinib Citrate | Tablet; Oral | ORIG-2 | Micro Labs | Approved | |
| Tofacitinib Citrate
ANDA #215356 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Tofacitinib Citrate
ANDA #217298 |
Tofacitinib Citrate | Solution; Oral | ORIG-1 | Msn | Approved | |
| Tofacitinib Citrate
ANDA #217299 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Msn | Approved | |
| Tofacitinib Citrate
ANDA #218096 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Apotex | Approved | |
| Tofacitinib Citrate
ANDA #218407 |
Tofacitinib Citrate | Solution; Oral | ORIG-1 | Sun Pharm Inds Inc | Approved | |
| Tofacitinib Citrate
ANDA #219395 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Specgx Llc | Approved | |
| Tofacitinib Citrate
ANDA #219530 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Tofacitinib Citrate
ANDA #220137 |
Tofacitinib Citrate | Tablet; Oral | ORIG-1 | Somerset Theraps Llc | Approved | |
| Tofacitinib Citrate
ANDA #220458 |
Tofacitinib Citrate | Tablet, Extended Release; Oral | ORIG-1 | Apotex | Approved | |
| Tofacitinib Citrate
ANDA #220458 |
Tofacitinib Citrate | Tablet, Extended Release; Oral | ORIG-2 | Apotex | Tentative Approval | |
| Vasopressin
ANDA #213988 |
Vasopressin | Solution; Intravenous | SUPPL-2 | Dr Reddys | Manufacturing (CMC) | Approved |
| Vasopressin
ANDA #213988 |
Vasopressin | Solution; Intravenous | SUPPL-3 | Dr Reddys | Manufacturing (CMC) | Approved |
| Vasopressin In Dextrose 5%
ANDA #213988 |
Vasopressin | Solution; Intravenous | SUPPL-2 | Dr Reddys | Manufacturing (CMC) | Approved |
| Vasopressin In Dextrose 5%
ANDA #213988 |
Vasopressin | Solution; Intravenous | SUPPL-3 | Dr Reddys | Manufacturing (CMC) | Approved |
June 2, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arsenic Trioxide
ANDA #206228 |
Arsenic Trioxide | Injectable; Injection | SUPPL-13 | Zydus Pharms | Labeling | Approved |
| Eluxadoline
ANDA #213511 |
Eluxadoline | Tablet; Oral | ORIG-1 | Aurobindo Pharma | Approved | |
| Furosemide
NDA #018569 |
Furosemide | Tablet; Oral | SUPPL-71 | Epic Pharma Llc | Labeling | Approved |
| Furosemide
NDA #018569 |
Furosemide | Tablet; Oral | SUPPL-71 | Epic Pharma Llc | Labeling | Approved |
| Leflunomide
ANDA #077083 |
Leflunomide | Tablet; Oral | SUPPL-9 | Barr | Labeling | Approved |
| Leflunomide
ANDA #077083 |
Leflunomide | Tablet; Oral | SUPPL-8 | Barr | Labeling | Approved |
| Leflunomide
ANDA #077083 |
Leflunomide | Tablet; Oral | SUPPL-9 | Barr | Labeling | Approved |
| Oxcarbazepine
ANDA #215332 |
Oxcarbazepine | Suspension; Oral | SUPPL-6 | Aucta | Labeling | Approved |
| Ranluspec
BLA #761480 |
Ranibizumab-Hkdz | Injection | ORIG-1 | Lupin Limited | Type 2 - New Active Ingredient | Approved |
| Romidepsin
ANDA #219099 |
Romidepsin | Solution; Intravenous | ORIG-1 | Amneal | Approved | |
| Saxenda
NDA #206321 |
Liraglutide | Solution; Subcutaneous | SUPPL-24 | Novo | Labeling | Approved |
| Saxenda
NDA #206321 |
Liraglutide | Solution; Subcutaneous | SUPPL-24 | Novo | Labeling | Approved |
| Tiocystin
NDA #212927 |
Tiopronin | Tablet; Oral | ORIG-1 | Casper Pharma Llc | Type 5 - New Formulation or New Manufacturer | Approved |
June 1, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Afinitor
NDA #022334 |
Everolimus | Tablet; Oral | SUPPL-55 | Novartis | Labeling | Approved |
| Afinitor Disperz
NDA #203985 |
Everolimus | Tablet, For Suspension; Oral | SUPPL-28 | Novartis Pharm | Labeling | Approved |
| Belzutifan
ANDA #220866 |
Belzutifan | Tablet | ORIG-1 | Hetero Labs Limited | Tentative Approval | |
| Cyclosporine
ANDA #219288 |
Cyclosporine | Emulsion; Ophthalmic | ORIG-1 | Jiangsu Anbison | Approved | |
| Diazepam
ANDA #070311 |
Diazepam | Injectable; Injection | SUPPL-28 | Hikma | Manufacturing (CMC) | Approved |
| Diazepam
ANDA #070311 |
Diazepam | Injectable; Injection | SUPPL-28 | Hikma | Manufacturing (CMC) | Approved |
| Eribulin Mesylate
ANDA #217085 |
Eribulin Mesylate | Solution; Intravenous | ORIG-1 | Natco | Approved | |
| Fluorescein Sodium
ANDA #218651 |
Fluorescein Sodium | Injectable; Intravenous | ORIG-1 | Zydus Lifesciences | Approved | |
| Lurasidone Hydrochloride
ANDA #208047 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-3 | Dr Reddys | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208047 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-4 | Dr Reddys | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208047 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-3 | Dr Reddys | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208047 |
Lurasidone Hydrochloride | Tablet; Oral | SUPPL-4 | Dr Reddys | Labeling | Approved |
| Methylprednisolone
ANDA #206751 |
Methylprednisolone | Tablet; Oral | SUPPL-10 | Zydus Pharms | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #218566 |
Mycophenolate Mofetil | For Suspension; Oral | ORIG-1 | Concord Biotech Ltd | Approved | |
| Ozempic
NDA #209637 |
Semaglutide | Solution; Subcutaneous | SUPPL-38 | Novo | Labeling | Approved |
| Pemigatinib
ANDA #219552 |
Pemigatinib | Tablet | ORIG-1 | Sandoz Inc | Tentative Approval | |
| Phytonadione
ANDA #217734 |
Phytonadione | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Soliris
BLA #125166 |
Eculizumab | Injectable; Iv (Infusion) | SUPPL-453 | Alexion Pharm | REMS | Approved |
| Ultomiris
BLA #761108 |
Ravulizumab-Cwvz | Injectable; Injection | SUPPL-45 | Alexion Pharm | REMS | Approved |