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.
December 5, 2022
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Blincyto
BLA #125557 |
Blinatumomab | Injectable; Injection | SUPPL-25 | Amgen | REMS | Approved |
| Sporanox
NDA #020083 |
Itraconazole | Capsule; Oral | SUPPL-65 | Janssen Pharms | Labeling | Approved |
| Sporanox
NDA #020657 |
Itraconazole | Solution; Oral | SUPPL-38 | Janssen Pharms | Labeling | Approved |
December 2, 2022
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Esmolol Hydrochloride
ANDA #214172 |
Esmolol Hydrochloride | Injectable; Injection | ORIG-1 | Hq Spclt Pharma | Approved | |
| Olmesartan Medoxomil
ANDA #206720 |
Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Prinston Inc | Approved | |
| Prednisone
ANDA #088832 |
Prednisone | Tablet; Oral | SUPPL-44 | Mylan | Manufacturing (CMC) | Approved |
| Qudexy Xr
NDA #205122 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-14 | Upsher Smith Labs | Labeling | Approved |
| Risperdal
NDA #020272 |
Risperidone | Tablet; Oral | SUPPL-87 | Janssen Pharms | Labeling | Approved |
| Risperdal
NDA #021444 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-59 | Janssen Pharms | Labeling | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-50 | Genentech Inc | Efficacy | Approved |
| Trelegy Ellipta
NDA #209482 |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-16 | Glaxosmithkline | Labeling | Approved |
December 1, 2022
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lovenox
NDA #020164 |
Enoxaparin Sodium | Injectable; Intravenous, Subcutaneous | SUPPL-131 | Sanofi Aventis Us | Labeling | Approved |
| Lovenox (Preservative Free)
NDA #020164 |
Enoxaparin Sodium | Injectable; Subcutaneous | SUPPL-131 | Sanofi Aventis Us | Labeling | Approved |
| Rezlidhia
NDA #215814 |
Olutasidenib | Capsule; Oral | ORIG-1 | Forma Therapeutics, Inc | Type 1 - New Molecular Entity | Approved |
| Unisom
NDA #018066 |
Doxylamine Succinate | Tablet; Oral | SUPPL-21 | Chattem | Labeling | Approved |
November 30, 2022
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abilify
NDA #021436 |
Aripiprazole | Tablet; Oral | SUPPL-48 | Otsuka | Labeling | Approved |
| Abilify Mycite Kit
NDA #207202 |
Aripiprazole | Tablet; Oral | SUPPL-6 | Otsuka | Labeling | Approved |
| Apidra
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Intravenous, Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Apidra
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Intravenous, Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Apidra Solostar
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Apidra Solostar
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Brexafemme
NDA #214900 |
Ibrexafungerp Citrate | Tablet; Oral | SUPPL-2 | Scynexis | Efficacy | Approved |
| Oxcarbazepine
ANDA #215332 |
Oxcarbazepine | Suspension; Oral | ORIG-1 | Aucta | Approved | |
| Posaconazole
ANDA #207355 |
Posaconazole | Tablet, Delayed Release; Oral | ORIG-1 | Actavis Labs Fl Inc | Approved |
November 29, 2022
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Diclofenac Sodium
ANDA #212506 |
Diclofenac Sodium | Solution; Topical | ORIG-1 | Aleor Dermaceuticals | Approved | |
| Escitalopram Oxalate
ANDA #202221 |
Escitalopram Oxalate | Solution; Oral | SUPPL-9 | Hetero Labs Ltd Iii | Labeling | Approved |
| Escitalopram Oxalate
ANDA #202221 |
Escitalopram Oxalate | Solution; Oral | SUPPL-9 | Hetero Labs Ltd Iii | Labeling | Approved |
| Escitalopram Oxalate
ANDA #202754 |
Escitalopram Oxalate | Solution; Oral | SUPPL-16 | Macleods Pharms Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #202754 |
Escitalopram Oxalate | Solution; Oral | SUPPL-16 | Macleods Pharms Ltd | Labeling | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-1 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-2 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-3 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-4 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-1 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-2 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-3 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-4 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Kimmtrak
BLA #761228 |
Tebentafusp-Tebn | Injectable; Injection | SUPPL-2 | Immunocore Ltd | Labeling | Approved |
| Naltrexone Hydrochloride; Bupropion Hydrochloride
ANDA #208043 |
Naltrexone Hydrochloride;Bupropion Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Actavis Labs Fl Inc | Tentative Approval |
November 28, 2022
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arformoterol Tartrate
ANDA #216815 |
Arformoterol Tartrate | Solution; Inhalation | ORIG-1 | Slayback Pharma Llc | Approved | |
| Carbidopa and Levodopa
ANDA #216537 |
Carbidopa; Levodopa | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-9 | Celltrion | Labeling | Approved |
| Dicyclomine Hydrochloride
ANDA #216760 |
Dicyclomine Hydrochloride | Tablet; Oral | ORIG-1 | Corepharma | Approved | |
| Dofetilide
ANDA #208625 |
Dofetilide | Capsule; Oral | SUPPL-4 | Bionpharma Inc | Labeling | Approved |
| Gemfibrozil
ANDA #078599 |
Gemfibrozil | Tablet; Oral | SUPPL-4 | Hikma Pharms | Labeling | Approved |
| Goprelto
NDA #209963 |
Cocaine Hydrochloride | Solution; Nasal | SUPPL-4 | Genus Lifesciences | Labeling | Approved |
| Goprelto
NDA #209963 |
Cocaine Hydrochloride | Solution; Nasal | SUPPL-4 | Genus Lifesciences | Labeling | Approved |
| Latanoprost
ANDA #202442 |
Latanoprost | Solution/Drops; Ophthalmic | SUPPL-9 | Fdc Ltd | Labeling | Approved |
| Latanoprost
ANDA #202442 |
Latanoprost | Solution/Drops; Ophthalmic | SUPPL-9 | Fdc Ltd | Labeling | Approved |
| Ofloxacin
ANDA #215886 |
Ofloxacin | Solution/Drops; Ophthalmic | ORIG-1 | Mankind Pharma | Approved | |
| Prochlorperazine Edisylate
ANDA #214192 |
Prochlorperazine Edisylate | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Prohance
NDA #020131 |
Gadoteridol | Injectable; Injection | SUPPL-37 | Bracco | Labeling | Approved |
| Udenyca
BLA #761039 |
Pegfilgrastim-Cbqv | Injectable; Injection | SUPPL-14 | Coherus Biosciences Inc | Efficacy | Approved |
| Ursodiol
ANDA #214849 |
Ursodiol | Capsule; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Venlafaxine Hydrochloride
ANDA #216044 |
Venlafaxine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Jb Chems Pharms | Approved |
December 5, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Blincyto
BLA #125557 |
Blinatumomab | Injectable; Injection | SUPPL-25 | Amgen | REMS | Approved |
| Sporanox
NDA #020083 |
Itraconazole | Capsule; Oral | SUPPL-65 | Janssen Pharms | Labeling | Approved |
| Sporanox
NDA #020657 |
Itraconazole | Solution; Oral | SUPPL-38 | Janssen Pharms | Labeling | Approved |
December 2, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Esmolol Hydrochloride
ANDA #214172 |
Esmolol Hydrochloride | Injectable; Injection | ORIG-1 | Hq Spclt Pharma | Approved | |
| Olmesartan Medoxomil
ANDA #206720 |
Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Prinston Inc | Approved | |
| Prednisone
ANDA #088832 |
Prednisone | Tablet; Oral | SUPPL-44 | Mylan | Manufacturing (CMC) | Approved |
| Qudexy Xr
NDA #205122 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-14 | Upsher Smith Labs | Labeling | Approved |
| Risperdal
NDA #020272 |
Risperidone | Tablet; Oral | SUPPL-87 | Janssen Pharms | Labeling | Approved |
| Risperdal
NDA #021444 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-59 | Janssen Pharms | Labeling | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-50 | Genentech Inc | Efficacy | Approved |
| Trelegy Ellipta
NDA #209482 |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Powder; Inhalation | SUPPL-16 | Glaxosmithkline | Labeling | Approved |
December 1, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lovenox
NDA #020164 |
Enoxaparin Sodium | Injectable; Intravenous, Subcutaneous | SUPPL-131 | Sanofi Aventis Us | Labeling | Approved |
| Lovenox (Preservative Free)
NDA #020164 |
Enoxaparin Sodium | Injectable; Subcutaneous | SUPPL-131 | Sanofi Aventis Us | Labeling | Approved |
| Rezlidhia
NDA #215814 |
Olutasidenib | Capsule; Oral | ORIG-1 | Forma Therapeutics, Inc | Type 1 - New Molecular Entity | Approved |
| Unisom
NDA #018066 |
Doxylamine Succinate | Tablet; Oral | SUPPL-21 | Chattem | Labeling | Approved |
November 30, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abilify
NDA #021436 |
Aripiprazole | Tablet; Oral | SUPPL-48 | Otsuka | Labeling | Approved |
| Abilify Mycite Kit
NDA #207202 |
Aripiprazole | Tablet; Oral | SUPPL-6 | Otsuka | Labeling | Approved |
| Apidra
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Intravenous, Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Apidra
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Intravenous, Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Apidra Solostar
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Apidra Solostar
BLA #021629 |
Insulin Glulisine Recombinant | Injectable; Subcutaneous | SUPPL-42 | Sanofi Aventis Us | Labeling | Approved |
| Brexafemme
NDA #214900 |
Ibrexafungerp Citrate | Tablet; Oral | SUPPL-2 | Scynexis | Efficacy | Approved |
| Oxcarbazepine
ANDA #215332 |
Oxcarbazepine | Suspension; Oral | ORIG-1 | Aucta | Approved | |
| Posaconazole
ANDA #207355 |
Posaconazole | Tablet, Delayed Release; Oral | ORIG-1 | Actavis Labs Fl Inc | Approved |
November 29, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Diclofenac Sodium
ANDA #212506 |
Diclofenac Sodium | Solution; Topical | ORIG-1 | Aleor Dermaceuticals | Approved | |
| Escitalopram Oxalate
ANDA #202221 |
Escitalopram Oxalate | Solution; Oral | SUPPL-9 | Hetero Labs Ltd Iii | Labeling | Approved |
| Escitalopram Oxalate
ANDA #202221 |
Escitalopram Oxalate | Solution; Oral | SUPPL-9 | Hetero Labs Ltd Iii | Labeling | Approved |
| Escitalopram Oxalate
ANDA #202754 |
Escitalopram Oxalate | Solution; Oral | SUPPL-16 | Macleods Pharms Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #202754 |
Escitalopram Oxalate | Solution; Oral | SUPPL-16 | Macleods Pharms Ltd | Labeling | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-1 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-2 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-3 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Solution; Oral | ORIG-4 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-1 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-2 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-3 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Jylamvo
NDA #212479 |
Methotrexate | Suspension; Oral | ORIG-4 | Therakind Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Kimmtrak
BLA #761228 |
Tebentafusp-Tebn | Injectable; Injection | SUPPL-2 | Immunocore Ltd | Labeling | Approved |
| Naltrexone Hydrochloride; Bupropion Hydrochloride
ANDA #208043 |
Naltrexone Hydrochloride;Bupropion Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Actavis Labs Fl Inc | Tentative Approval |
November 28, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arformoterol Tartrate
ANDA #216815 |
Arformoterol Tartrate | Solution; Inhalation | ORIG-1 | Slayback Pharma Llc | Approved | |
| Carbidopa and Levodopa
ANDA #216537 |
Carbidopa; Levodopa | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-9 | Celltrion | Labeling | Approved |
| Dicyclomine Hydrochloride
ANDA #216760 |
Dicyclomine Hydrochloride | Tablet; Oral | ORIG-1 | Corepharma | Approved | |
| Dofetilide
ANDA #208625 |
Dofetilide | Capsule; Oral | SUPPL-4 | Bionpharma Inc | Labeling | Approved |
| Gemfibrozil
ANDA #078599 |
Gemfibrozil | Tablet; Oral | SUPPL-4 | Hikma Pharms | Labeling | Approved |
| Goprelto
NDA #209963 |
Cocaine Hydrochloride | Solution; Nasal | SUPPL-4 | Genus Lifesciences | Labeling | Approved |
| Goprelto
NDA #209963 |
Cocaine Hydrochloride | Solution; Nasal | SUPPL-4 | Genus Lifesciences | Labeling | Approved |
| Latanoprost
ANDA #202442 |
Latanoprost | Solution/Drops; Ophthalmic | SUPPL-9 | Fdc Ltd | Labeling | Approved |
| Latanoprost
ANDA #202442 |
Latanoprost | Solution/Drops; Ophthalmic | SUPPL-9 | Fdc Ltd | Labeling | Approved |
| Ofloxacin
ANDA #215886 |
Ofloxacin | Solution/Drops; Ophthalmic | ORIG-1 | Mankind Pharma | Approved | |
| Prochlorperazine Edisylate
ANDA #214192 |
Prochlorperazine Edisylate | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Prohance
NDA #020131 |
Gadoteridol | Injectable; Injection | SUPPL-37 | Bracco | Labeling | Approved |
| Udenyca
BLA #761039 |
Pegfilgrastim-Cbqv | Injectable; Injection | SUPPL-14 | Coherus Biosciences Inc | Efficacy | Approved |
| Ursodiol
ANDA #214849 |
Ursodiol | Capsule; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Venlafaxine Hydrochloride
ANDA #216044 |
Venlafaxine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Jb Chems Pharms | Approved |
November 25, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carfilzomib
ANDA #210823 |
Carfilzomib | Powder; Intravenous | ORIG-1 | Eugia Pharma | Tentative Approval | |
| Eligard Kit
NDA #021731 |
Leuprolide Acetate | Powder; Subcutaneous | SUPPL-43 | Tolmar Therap | Manufacturing (CMC) | Approved |
| Fensolvi Kit
NDA #213150 |
Leuprolide Acetate | Powder; Subcutaneous | SUPPL-3 | Tolmar | Manufacturing (CMC) | Approved |
| Formoterol Fumarate
ANDA #216486 |
Formoterol Fumarate | Solution; Inhalation | ORIG-1 | Aucta | Approved | |
| Levothyroxine Sodium
ANDA #217066 |
Levothyroxine Sodium | Injectable; Injection | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Lisdexamfetamine Dimesylate
ANDA #215415 |
Lisdexamfetamine Dimesylate | Tablet, Chewable; Oral | ORIG-1 | Teva Pharms Inc | Tentative Approval | |
| Neostigmine Methysulfate
ANDA #208230 |
Neostigmine Methylsulfate | Solution; Intravenous | ORIG-1 | Avet Lifesciences | Approved | |
| Nevirapine
ANDA #203411 |
Nevirapine | Tablet, Extended Release; Oral | SUPPL-8 | Sandoz Inc | Labeling | Approved |
| Nevirapine
ANDA #203411 |
Nevirapine | Tablet, Extended Release; Oral | SUPPL-8 | Sandoz Inc | Labeling | Approved |
| Ramelteon
ANDA #216209 |
Ramelteon | Tablet; Oral | ORIG-1 | Xiromed | Approved | |
| Valbenazine Tosylate
ANDA #215984 |
Valbenazine Tosylate | Capsule; Oral | ORIG-1 | Teva Pharms Inc | Tentative Approval |
November 23, 2022
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Atorvastatin Calcium
ANDA #216436 |
Atorvastatin Calcium | Tablet; Oral | ORIG-1 | Biocon Pharma | Approved | |
| Atropine Sulfate
ANDA #212868 |
Atropine Sulfate | Solution; Intravenous | SUPPL-2 | Accord Hlthcare | Manufacturing (CMC) | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-19 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-19 | Aurobindo Pharma Ltd | Labeling | Approved |
| Niacin
ANDA #090446 |
Niacin | Tablet, Extended Release; Oral | SUPPL-12 | Lupin Ltd | Labeling | Approved |
| Niacin
ANDA #090446 |
Niacin | Tablet, Extended Release; Oral | SUPPL-12 | Lupin Ltd | Labeling | Approved |
| Niacin
ANDA #090860 |
Niacin | Tablet, Extended Release; Oral | SUPPL-12 | Lupin Ltd | Labeling | Approved |
| Niacin
ANDA #090860 |
Niacin | Tablet, Extended Release; Oral | SUPPL-12 | Lupin Ltd | Labeling | Approved |
| Niacin
ANDA #090892 |
Niacin | Tablet, Extended Release; Oral | SUPPL-12 | Lupin Ltd | Labeling | Approved |
| Niacin
ANDA #090892 |
Niacin | Tablet, Extended Release; Oral | SUPPL-12 | Lupin Ltd | Labeling | Approved |
| Novolin 70/30
BLA #019991 |
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human | Injectable; Injection | SUPPL-85 | Novo Nordisk Inc | Labeling | Approved |
| Novolin 70/30
BLA #019991 |
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human | Injectable; Injection | SUPPL-85 | Novo Nordisk Inc | Labeling | Approved |
| Novolin 70/30
BLA #019991 |
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human | Injectable; Injection | SUPPL-85 | Novo Nordisk Inc | Labeling | Approved |
| Novolin N
BLA #019959 |
Insulin Susp Isophane Recombinant Human | Injectable; Injection | SUPPL-85 | Novo Nordisk Inc | Labeling | Approved |
| Novolin N
BLA #019959 |
Insulin Susp Isophane Recombinant Human | Injectable; Injection | SUPPL-85 | Novo Nordisk Inc | Labeling | Approved |
| Novolin N
BLA #019959 |
Insulin Susp Isophane Recombinant Human | Injectable; Injection | SUPPL-85 | Novo Nordisk Inc | Labeling | Approved |
| Novolin R
BLA #019938 |
Insulin Recombinant Human | Injectable; Injection | SUPPL-82 | Novo Nordisk Inc | Labeling | Approved |
| Novolin R
BLA #019938 |
Insulin Recombinant Human | Injectable; Injection | SUPPL-82 | Novo Nordisk Inc | Labeling | Approved |
| Novolin R
BLA #019938 |
Insulin Recombinant Human | Injectable; Injection | SUPPL-82 | Novo Nordisk Inc | Labeling | Approved |
| Vitrakvi
NDA #210861 |
Larotrectinib Sulfate | Capsule; Oral | SUPPL-8 | Bayer Hlthcare | Labeling | Approved |
| Vitrakvi
NDA #211710 |
Larotrectinib Sulfate | Solution; Oral | SUPPL-8 | Bayer Healthcare | Labeling | Approved |
| Voltaren Arthritis Pain
NDA #022122 |
Diclofenac Sodium | Gel; Topical | SUPPL-22 | Glaxosmithkline Cons | Manufacturing (CMC) | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-130 | Bristol Myers Squibb | Labeling | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-130 | Bristol Myers Squibb | Labeling | Approved |
| Zegerid Otc
NDA #022283 |
Omeprazole; Sodium Bicarbonate | For Suspension; Oral | SUPPL-4 | Riley Consumer | Labeling | Approved |