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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.

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
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