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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.

May 30, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fintepla
NDA #212102
Fenfluramine Hydrochloride Solution; Oral SUPPL-9 Zogenix Inc REMS Approved
Obeticholic Acid
ANDA #214862
Obeticholic Acid Tablet; Oral ORIG-1 Apotex Inc Approved
Obeticholic Acid
ANDA #214980
Obeticholic Acid Tablet; Oral ORIG-1 Lupin Ltd Approved
Semglee
BLA #761201
Insulin Glargine-Yfgn Injectable; Injection SUPPL-7 Mylan Pharms Inc Labeling Approved
Vevye
NDA #217469
Cyclosporine Solution; Ophthalmic ORIG-1 Novaliq Gmbh Type 5 - New Formulation or New Manufacturer Approved

May 28, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #207857
Albuterol Sulfate Solution; Inhalation SUPPL-8 Sun Pharm Labeling Approved
Albuterol Sulfate
ANDA #207857
Albuterol Sulfate Solution; Inhalation SUPPL-8 Sun Pharm Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-30 Pliva Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-30 Pliva Labeling Approved

May 26, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apixaban
ANDA #210026
Apixaban Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Dolutegravir, Emtricitabine and Tenofovir Alafenamide
NDA #215448
Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablet; Oral ORIG-1 Aurobindo Pharma Usa Type 4 - New Combination Tentative Approval
Inpefa
NDA #216203
Sotagliflozin Tablet; Oral ORIG-1 Lexicon Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Itraconazole
ANDA #076104
Itraconazole Capsule; Oral SUPPL-24 Sandoz Labeling Approved
Itraconazole
ANDA #076104
Itraconazole Capsule; Oral SUPPL-24 Sandoz Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-5 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #209460
Itraconazole Capsule; Oral SUPPL-4 Torrent Labeling Approved
Itraconazole
ANDA #209460
Itraconazole Capsule; Oral SUPPL-4 Torrent Labeling Approved
Itraconazole
ANDA #212239
Itraconazole Solution; Oral SUPPL-1 Annora Pharma Labeling Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-28 Novartis Labeling Approved
Metformin Hydrochloride
ANDA #213320
Metformin Hydrochloride Tablet; Oral SUPPL-2 Harman Finochem Manufacturing (CMC) Approved
Opsumit
NDA #204410
Macitentan Tablet; Oral SUPPL-24 Actelion Labeling Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-1 Xiamen Lp Pharm Co Labeling Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-1 Xiamen Lp Pharm Co Labeling Approved
Sevelamer Hydrochloride
ANDA #206883
Sevelamer Hydrochloride Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-26 Novartis Labeling Approved
Tezspire
BLA #761224
Tezepelumab-Ekko Solution; Subcutaneous SUPPL-3 Astrazeneca Ab Labeling Approved
Timolol Maleate
ANDA #217343
Timolol Maleate Solution/Drops; Ophthalmic ORIG-1 Micro Labs Approved
Vasopressin
ANDA #213205
Vasopressin Injectable; Injection ORIG-1 Fresenius Kabi Usa Tentative Approval
Vasopressin
ANDA #213206
Vasopressin Solution; Intravenous ORIG-1 Fresenius Kabi Usa Approved
Zinplava
BLA #761046
Bezlotoxumab Injectable; Injection SUPPL-12 Merck Sharp Dohme Efficacy Approved

May 25, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203136
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-44 Amneal Pharms Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Alkem Labs Ltd Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Alkem Labs Ltd Labeling Approved
Carboprost Tromethamine
ANDA #216939
Carboprost Tromethamine Injectable; Injection ORIG-1 Eugia Pharma Approved
Chlordiazepoxide Hydrochloride and Clidinium Bromide
ANDA #214065
Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral SUPPL-5 Alkem Labs Ltd Labeling Approved
Claritin Hives Relief Reditab
NDA #020704
Loratadine Tablet, Orally Disintegrating; Oral SUPPL-41 Bayer Healthcare Llc Labeling Approved
Claritin Reditabs
NDA #020704
Loratadine Tablet, Orally Disintegrating; Oral SUPPL-41 Bayer Healthcare Llc Labeling Approved
Claritin Reditabs
NDA #021993
Loratadine Tablet, Orally Disintegrating; Oral SUPPL-23 Bayer Healthcare Llc Labeling Approved
Eptifibatide
ANDA #206127
Eptifibatide Injectable; Injection SUPPL-4 Eugia Pharma Labeling Approved
Margenza
BLA #761150
Margetuximab-Cmkb Injectable; Injection SUPPL-5 Macrogenics Inc Efficacy Approved
Nitisinone
ANDA #216201
Nitisinone Capsule; Oral ORIG-1 Zenara Approved
Palonosetron Hydrochloride
ANDA #205870
Palonosetron Hydrochloride Injectable; Intravenous SUPPL-3 Sagent Pharms Inc Labeling Approved
Paxlovid
NDA #217188
Ritonavir, Nirmatrelvir Tablet; Oral ORIG-1 Pfizer Inc Type 1 - New Molecular Entity Approved
Posluma
NDA #216023
Flotufolastat F-18 Injectable; Intravenous ORIG-1 Blue Earth Diagnostics Ltd. Type 1 - New Molecular Entity Approved
Sustol
NDA #022445
Granisetron Injection, Extended Release; Subcutaneous SUPPL-10 Heron Theraps Inc Labeling Approved
Sustol
NDA #022445
Granisetron Injection, Extended Release; Subcutaneous SUPPL-10 Heron Theraps Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-32 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-33 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-32 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-33 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-22 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-22 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Triazolam
ANDA #213003
Triazolam Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Triazolam
ANDA #213003
Triazolam Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Ultravist (Pharmacy Bulk)
NDA #021425
Iopromide Injectable; Injection SUPPL-36 Bayer Hlthcare Efficacy Approved
Ultravist 150
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 240
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 300
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 300 In Plastic Container
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 370
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved

May 24, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #205530
Acetazolamide Tablet; Oral SUPPL-11 Heritage Pharma Labeling Approved
Dextromethorphan Hydrobromide and Quinidine Sulfate
ANDA #202934
Dextromethorphan Hydrobromide; Quinidine Sulfate Capsule; Oral SUPPL-1 Actavis Elizabeth Labeling Approved
Imipramine Hydrochloride
ANDA #083745
Imipramine Hydrochloride Tablet; Oral SUPPL-123 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #083745
Imipramine Hydrochloride Tablet; Oral SUPPL-123 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084936
Imipramine Hydrochloride Tablet; Oral SUPPL-109 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084936
Imipramine Hydrochloride Tablet; Oral SUPPL-109 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084937
Imipramine Hydrochloride Tablet; Oral SUPPL-129 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084937
Imipramine Hydrochloride Tablet; Oral SUPPL-129 Sandoz Labeling Approved
Lisdexamfetamine Dimesylate
ANDA #216266
Lisdexamfetamine Dimesylate Capsule; Oral ORIG-1 Prinston Pharma Inc Tentative Approval
Lumizyme
BLA #125291
Alglucosidase Alfa Powder; Iv (Infusion) SUPPL-159 Genzyme Labeling Approved
Methimazole
ANDA #209827
Methimazole Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Metronidazole In Plastic Container
ANDA #217665
Metronidazole In Plastic Container Injectable; Injection ORIG-1 Amneal Approved
Nasonex 24hr Allergy
NDA #215712
Mometasone Furoate Spray, Metered; Nasal SUPPL-15 Perrigo Pharma Intl Labeling Approved
Norethindrone
ANDA #091209
Norethindrone Tablet; Oral-28 SUPPL-10 Glenmark Generics Labeling Approved
Norethindrone
ANDA #091209
Norethindrone Tablet; Oral-28 SUPPL-10 Glenmark Generics Labeling Approved
Ondansetron Hydrochloride
ANDA #206846
Ondansetron Hydrochloride Injectable; Injection SUPPL-8 Accord Hlthcare Labeling Approved
Ondansetron Hydrochloride Preservative Free
ANDA #206845
Ondansetron Hydrochloride Injectable; Injection SUPPL-8 Accord Hlthcare Labeling Approved
Oxybutynin Chloride
ANDA #206121
Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-6 Unique Labeling Approved
Pazopanib
ANDA #215837
Pazopanib Tablet; Oral ORIG-1 Sun Pharm Inds Ltd Tentative Approval
Readyprep Chg
NDA #207964
Chlorhexidine Gluconate Cloth; Topical SUPPL-3 Medline Industries Manufacturing (CMC) Approved
Risedronate Sodium
ANDA #079215
Risedronate Sodium Tablet; Oral SUPPL-4 Teva Pharms Usa Labeling Approved
Risedronate Sodium
ANDA #079215
Risedronate Sodium Tablet; Oral SUPPL-4 Teva Pharms Usa Labeling Approved
Rocuronium Bromide
ANDA #217034
Rocuronium Bromide Injectable; Injection ORIG-1 Hikma Approved
Tofacitinib
ANDA #216940
Tofacitinib Tablet; Oral ORIG-1 Heilongjiang Zbd Pharmaceutical Co Ltd Tentative Approval
Venlafaxine Hydrochloride
ANDA #214419
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved
Venlafaxine Hydrochloride
ANDA #214419
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved

May 23, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Baclofen
ANDA #090334
Baclofen Tablet; Oral SUPPL-3 Appco Labeling Approved
Brixadi
NDA #210136
Buprenorphine Injection, Extended Release; Subcutaneous ORIG-1 Braeburn Pharma Inc Type 3 - New Dosage Form Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-23 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-15 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-21 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-15 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-21 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-23 Alvogen Labeling Approved
Chorionic Gonadotropin
BLA #017016
Gonadotropin, Chorionic Injectable; Injection SUPPL-172 Ferring Labeling Approved
Divigel
NDA #022038
Estradiol Gel; Transdermal SUPPL-10 Vertical Pharms Labeling Approved
Exemestane
ANDA #200898
Exemestane Tablet; Oral SUPPL-12 Alvogen Labeling Approved
Fexofenadine Hydrochloride
ANDA #213466
Fexofenadine Hydrochloride Suspension; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-4 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-5 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-8 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-9 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-4 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-6 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-8 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-9 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Haloperidol Decanoate
ANDA #216730
Haloperidol Decanoate Injectable; Injection ORIG-1 Mankind Pharma Approved
Levetiracetam In Sodium Chloride
ANDA #206880
Levetiracetam Injectable; Intravenous SUPPL-7 Gland Pharma Ltd Labeling Approved
Levetiracetam In Sodium Chloride
ANDA #207160
Levetiracetam Injectable; Intravenous SUPPL-5 Eugia Pharma Labeling Approved
Methylphenidate Hydrochloride
ANDA #214447
Methylphenidate Hydrochloride Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #203580
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral SUPPL-18 Torrent Labeling Approved
Posaconazole
ANDA #214842
Posaconazole Injectable; Injection ORIG-1 Eugia Pharma Speclts Tentative Approval
Regadenoson
ANDA #217455
Regadenoson Solution; Intravenous ORIG-1 Baxter Hlthcare Corp Approved
Ropivacaine Hydrochloride
ANDA #090194
Ropivacaine Hydrochloride Solution; Injection SUPPL-2 Hospira Labeling Approved
Ropivacaine Hydrochloride
ANDA #090194
Ropivacaine Hydrochloride Solution; Injection SUPPL-5 Hospira Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-13 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-12 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-13 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-14 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-15 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-15 Micro Labs Labeling Approved
Tofacitinib
ANDA #216770
Tofacitinib Tablet; Oral ORIG-1 Teva Pharms Inc Tentative Approval
Xacduro
NDA #216974
Sulbactam;Durlobactam Injectable; Injection ORIG-1 Entasis Therapeutics Inc Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Yuflyma
BLA #761219
Adalimumab-Aaty Injectable; Injection ORIG-1 Celltrion Type 2 - New Active Ingredient Approved
Zolmitriptan
ANDA #202279
Zolmitriptan Tablet; Oral SUPPL-5 Jubilant Generics Labeling Approved

May 22, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ayvakit
NDA #212608
Avapritinib Tablet; Oral SUPPL-13 Blueprint Medicines Efficacy Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-9 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-9 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-7 Vistapharm Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-7 Vistapharm Labeling Approved
Clobazam
ANDA #210978
Clobazam Suspension; Oral SUPPL-6 Taro Labeling Approved
Clobazam
ANDA #210978
Clobazam Suspension; Oral SUPPL-6 Taro Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-5 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-4 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-5 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-4 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-5 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-11 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-11 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-3 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-3 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Indchemie Health Labeling Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Padagis Us Labeling Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Padagis Us Labeling Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Padagis Us Labeling Approved
Itraconazole
ANDA #206741
Itraconazole Capsule; Oral SUPPL-14 Alembic Labeling Approved
Itraconazole
ANDA #206741
Itraconazole Capsule; Oral SUPPL-14 Alembic Labeling Approved
Itraconazole
ANDA #206741
Itraconazole Capsule; Oral SUPPL-14 Alembic Labeling Approved
Levetiracetam
ANDA #201157
Levetiracetam Solution; Oral SUPPL-8 Pharm Assoc Labeling Approved
Levetiracetam
ANDA #204312
Levetiracetam Injectable; Intravenous SUPPL-9 Eugia Pharma Labeling Approved
Levetiracetam
ANDA #211954
Levetiracetam Injectable; Intravenous SUPPL-2 Micro Labs Labeling Approved
Levetiracetam
ANDA #211954
Levetiracetam Injectable; Intravenous SUPPL-1 Micro Labs Labeling Approved
Levetiracetam
ANDA #211954
Levetiracetam Injectable; Intravenous SUPPL-2 Micro Labs Labeling Approved
Levoleucovorin Calcium
ANDA #217314
Levoleucovorin Calcium Solution; Intravenous ORIG-1 Hainan Poly Pharm Approved
Opvee
NDA #217470
Nalmefene Spray; Nasal ORIG-1 Opiant Pharmaceuticals Inc Type 3 - New Dosage Form Approved
Pemetrexed
NDA #215179
Pemetrexed Solution; Intravenous ORIG-1 Shilpa Medicare Ltd Type 5 - New Formulation or New Manufacturer Approved
Rydapt
NDA #207997
Midostaurin Capsule; Oral SUPPL-10 Novartis Labeling Approved
Vigabatrin
ANDA #214961
Vigabatrin For Solution; Oral SUPPL-2 Pyros Pharms Labeling Approved
Vigabatrin
ANDA #214961
Vigabatrin For Solution; Oral SUPPL-2 Pyros Pharms Labeling Approved
Vigabatrin
ANDA #214961
Vigabatrin For Solution; Oral SUPPL-2 Pyros Pharms Labeling Approved

May 30, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fintepla
NDA #212102
Fenfluramine Hydrochloride Solution; Oral SUPPL-9 Zogenix Inc REMS Approved
Obeticholic Acid
ANDA #214862
Obeticholic Acid Tablet; Oral ORIG-1 Apotex Inc Approved
Obeticholic Acid
ANDA #214980
Obeticholic Acid Tablet; Oral ORIG-1 Lupin Ltd Approved
Semglee
BLA #761201
Insulin Glargine-Yfgn Injectable; Injection SUPPL-7 Mylan Pharms Inc Labeling Approved
Vevye
NDA #217469
Cyclosporine Solution; Ophthalmic ORIG-1 Novaliq Gmbh Type 5 - New Formulation or New Manufacturer Approved

May 28, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #207857
Albuterol Sulfate Solution; Inhalation SUPPL-8 Sun Pharm Labeling Approved
Albuterol Sulfate
ANDA #207857
Albuterol Sulfate Solution; Inhalation SUPPL-8 Sun Pharm Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-30 Pliva Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-30 Pliva Labeling Approved

May 26, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apixaban
ANDA #210026
Apixaban Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Dolutegravir, Emtricitabine and Tenofovir Alafenamide
NDA #215448
Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablet; Oral ORIG-1 Aurobindo Pharma Usa Type 4 - New Combination Tentative Approval
Inpefa
NDA #216203
Sotagliflozin Tablet; Oral ORIG-1 Lexicon Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Itraconazole
ANDA #076104
Itraconazole Capsule; Oral SUPPL-24 Sandoz Labeling Approved
Itraconazole
ANDA #076104
Itraconazole Capsule; Oral SUPPL-24 Sandoz Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-5 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #209460
Itraconazole Capsule; Oral SUPPL-4 Torrent Labeling Approved
Itraconazole
ANDA #209460
Itraconazole Capsule; Oral SUPPL-4 Torrent Labeling Approved
Itraconazole
ANDA #212239
Itraconazole Solution; Oral SUPPL-1 Annora Pharma Labeling Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-28 Novartis Labeling Approved
Metformin Hydrochloride
ANDA #213320
Metformin Hydrochloride Tablet; Oral SUPPL-2 Harman Finochem Manufacturing (CMC) Approved
Opsumit
NDA #204410
Macitentan Tablet; Oral SUPPL-24 Actelion Labeling Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-1 Xiamen Lp Pharm Co Labeling Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-1 Xiamen Lp Pharm Co Labeling Approved
Sevelamer Hydrochloride
ANDA #206883
Sevelamer Hydrochloride Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-26 Novartis Labeling Approved
Tezspire
BLA #761224
Tezepelumab-Ekko Solution; Subcutaneous SUPPL-3 Astrazeneca Ab Labeling Approved
Timolol Maleate
ANDA #217343
Timolol Maleate Solution/Drops; Ophthalmic ORIG-1 Micro Labs Approved
Vasopressin
ANDA #213205
Vasopressin Injectable; Injection ORIG-1 Fresenius Kabi Usa Tentative Approval
Vasopressin
ANDA #213206
Vasopressin Solution; Intravenous ORIG-1 Fresenius Kabi Usa Approved
Zinplava
BLA #761046
Bezlotoxumab Injectable; Injection SUPPL-12 Merck Sharp Dohme Efficacy Approved

May 25, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203136
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-44 Amneal Pharms Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Alkem Labs Ltd Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Alkem Labs Ltd Labeling Approved
Carboprost Tromethamine
ANDA #216939
Carboprost Tromethamine Injectable; Injection ORIG-1 Eugia Pharma Approved
Chlordiazepoxide Hydrochloride and Clidinium Bromide
ANDA #214065
Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral SUPPL-5 Alkem Labs Ltd Labeling Approved
Claritin Hives Relief Reditab
NDA #020704
Loratadine Tablet, Orally Disintegrating; Oral SUPPL-41 Bayer Healthcare Llc Labeling Approved
Claritin Reditabs
NDA #020704
Loratadine Tablet, Orally Disintegrating; Oral SUPPL-41 Bayer Healthcare Llc Labeling Approved
Claritin Reditabs
NDA #021993
Loratadine Tablet, Orally Disintegrating; Oral SUPPL-23 Bayer Healthcare Llc Labeling Approved
Eptifibatide
ANDA #206127
Eptifibatide Injectable; Injection SUPPL-4 Eugia Pharma Labeling Approved
Margenza
BLA #761150
Margetuximab-Cmkb Injectable; Injection SUPPL-5 Macrogenics Inc Efficacy Approved
Nitisinone
ANDA #216201
Nitisinone Capsule; Oral ORIG-1 Zenara Approved
Palonosetron Hydrochloride
ANDA #205870
Palonosetron Hydrochloride Injectable; Intravenous SUPPL-3 Sagent Pharms Inc Labeling Approved
Paxlovid
NDA #217188
Ritonavir, Nirmatrelvir Tablet; Oral ORIG-1 Pfizer Inc Type 1 - New Molecular Entity Approved
Posluma
NDA #216023
Flotufolastat F-18 Injectable; Intravenous ORIG-1 Blue Earth Diagnostics Ltd. Type 1 - New Molecular Entity Approved
Sustol
NDA #022445
Granisetron Injection, Extended Release; Subcutaneous SUPPL-10 Heron Theraps Inc Labeling Approved
Sustol
NDA #022445
Granisetron Injection, Extended Release; Subcutaneous SUPPL-10 Heron Theraps Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-32 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-33 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-32 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078235
Topiramate Tablet; Oral SUPPL-33 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-22 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-22 Zydus Pharms Usa Inc Labeling Approved
Topiramate
ANDA #078877
Topiramate Capsule; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Triazolam
ANDA #213003
Triazolam Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Triazolam
ANDA #213003
Triazolam Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Ultravist (Pharmacy Bulk)
NDA #021425
Iopromide Injectable; Injection SUPPL-36 Bayer Hlthcare Efficacy Approved
Ultravist 150
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 240
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 300
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 300 In Plastic Container
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved
Ultravist 370
NDA #020220
Iopromide Injectable; Injection SUPPL-54 Bayer Hlthcare Efficacy Approved

May 24, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #205530
Acetazolamide Tablet; Oral SUPPL-11 Heritage Pharma Labeling Approved
Dextromethorphan Hydrobromide and Quinidine Sulfate
ANDA #202934
Dextromethorphan Hydrobromide; Quinidine Sulfate Capsule; Oral SUPPL-1 Actavis Elizabeth Labeling Approved
Imipramine Hydrochloride
ANDA #083745
Imipramine Hydrochloride Tablet; Oral SUPPL-123 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #083745
Imipramine Hydrochloride Tablet; Oral SUPPL-123 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084936
Imipramine Hydrochloride Tablet; Oral SUPPL-109 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084936
Imipramine Hydrochloride Tablet; Oral SUPPL-109 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084937
Imipramine Hydrochloride Tablet; Oral SUPPL-129 Sandoz Labeling Approved
Imipramine Hydrochloride
ANDA #084937
Imipramine Hydrochloride Tablet; Oral SUPPL-129 Sandoz Labeling Approved
Lisdexamfetamine Dimesylate
ANDA #216266
Lisdexamfetamine Dimesylate Capsule; Oral ORIG-1 Prinston Pharma Inc Tentative Approval
Lumizyme
BLA #125291
Alglucosidase Alfa Powder; Iv (Infusion) SUPPL-159 Genzyme Labeling Approved
Methimazole
ANDA #209827
Methimazole Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Metronidazole In Plastic Container
ANDA #217665
Metronidazole In Plastic Container Injectable; Injection ORIG-1 Amneal Approved
Nasonex 24hr Allergy
NDA #215712
Mometasone Furoate Spray, Metered; Nasal SUPPL-15 Perrigo Pharma Intl Labeling Approved
Norethindrone
ANDA #091209
Norethindrone Tablet; Oral-28 SUPPL-10 Glenmark Generics Labeling Approved
Norethindrone
ANDA #091209
Norethindrone Tablet; Oral-28 SUPPL-10 Glenmark Generics Labeling Approved
Ondansetron Hydrochloride
ANDA #206846
Ondansetron Hydrochloride Injectable; Injection SUPPL-8 Accord Hlthcare Labeling Approved
Ondansetron Hydrochloride Preservative Free
ANDA #206845
Ondansetron Hydrochloride Injectable; Injection SUPPL-8 Accord Hlthcare Labeling Approved
Oxybutynin Chloride
ANDA #206121
Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-6 Unique Labeling Approved
Pazopanib
ANDA #215837
Pazopanib Tablet; Oral ORIG-1 Sun Pharm Inds Ltd Tentative Approval
Readyprep Chg
NDA #207964
Chlorhexidine Gluconate Cloth; Topical SUPPL-3 Medline Industries Manufacturing (CMC) Approved
Risedronate Sodium
ANDA #079215
Risedronate Sodium Tablet; Oral SUPPL-4 Teva Pharms Usa Labeling Approved
Risedronate Sodium
ANDA #079215
Risedronate Sodium Tablet; Oral SUPPL-4 Teva Pharms Usa Labeling Approved
Rocuronium Bromide
ANDA #217034
Rocuronium Bromide Injectable; Injection ORIG-1 Hikma Approved
Tofacitinib
ANDA #216940
Tofacitinib Tablet; Oral ORIG-1 Heilongjiang Zbd Pharmaceutical Co Ltd Tentative Approval
Venlafaxine Hydrochloride
ANDA #214419
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved
Venlafaxine Hydrochloride
ANDA #214419
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved

May 23, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Baclofen
ANDA #090334
Baclofen Tablet; Oral SUPPL-3 Appco Labeling Approved
Brixadi
NDA #210136
Buprenorphine Injection, Extended Release; Subcutaneous ORIG-1 Braeburn Pharma Inc Type 3 - New Dosage Form Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-23 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-15 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-21 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-15 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-21 Alvogen Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-23 Alvogen Labeling Approved
Chorionic Gonadotropin
BLA #017016
Gonadotropin, Chorionic Injectable; Injection SUPPL-172 Ferring Labeling Approved
Divigel
NDA #022038
Estradiol Gel; Transdermal SUPPL-10 Vertical Pharms Labeling Approved
Exemestane
ANDA #200898
Exemestane Tablet; Oral SUPPL-12 Alvogen Labeling Approved
Fexofenadine Hydrochloride
ANDA #213466
Fexofenadine Hydrochloride Suspension; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-4 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-5 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-8 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-9 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-4 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-6 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-8 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-9 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved
Gabapentin
ANDA #090335
Gabapentin Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Haloperidol Decanoate
ANDA #216730
Haloperidol Decanoate Injectable; Injection ORIG-1 Mankind Pharma Approved
Levetiracetam In Sodium Chloride
ANDA #206880
Levetiracetam Injectable; Intravenous SUPPL-7 Gland Pharma Ltd Labeling Approved
Levetiracetam In Sodium Chloride
ANDA #207160
Levetiracetam Injectable; Intravenous SUPPL-5 Eugia Pharma Labeling Approved
Methylphenidate Hydrochloride
ANDA #214447
Methylphenidate Hydrochloride Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #203580
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral SUPPL-18 Torrent Labeling Approved
Posaconazole
ANDA #214842
Posaconazole Injectable; Injection ORIG-1 Eugia Pharma Speclts Tentative Approval
Regadenoson
ANDA #217455
Regadenoson Solution; Intravenous ORIG-1 Baxter Hlthcare Corp Approved
Ropivacaine Hydrochloride
ANDA #090194
Ropivacaine Hydrochloride Solution; Injection SUPPL-2 Hospira Labeling Approved
Ropivacaine Hydrochloride
ANDA #090194
Ropivacaine Hydrochloride Solution; Injection SUPPL-5 Hospira Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-13 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-12 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-13 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-14 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-15 Micro Labs Labeling Approved
Simvastatin
ANDA #090383
Simvastatin Tablet; Oral SUPPL-15 Micro Labs Labeling Approved
Tofacitinib
ANDA #216770
Tofacitinib Tablet; Oral ORIG-1 Teva Pharms Inc Tentative Approval
Xacduro
NDA #216974
Sulbactam;Durlobactam Injectable; Injection ORIG-1 Entasis Therapeutics Inc Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Yuflyma
BLA #761219
Adalimumab-Aaty Injectable; Injection ORIG-1 Celltrion Type 2 - New Active Ingredient Approved
Zolmitriptan
ANDA #202279
Zolmitriptan Tablet; Oral SUPPL-5 Jubilant Generics Labeling Approved

May 22, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ayvakit
NDA #212608
Avapritinib Tablet; Oral SUPPL-13 Blueprint Medicines Efficacy Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-9 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #209718
Clobazam Tablet; Oral SUPPL-9 Amneal Pharms Co Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-7 Vistapharm Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-7 Vistapharm Labeling Approved
Clobazam
ANDA #210978
Clobazam Suspension; Oral SUPPL-6 Taro Labeling Approved
Clobazam
ANDA #210978
Clobazam Suspension; Oral SUPPL-6 Taro Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-5 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-4 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-5 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-4 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-5 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209647
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Amneal Pharms Ny Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-11 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-11 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #209735
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Sun Pharm Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-3 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-3 Indchemie Health Labeling Approved
Esomeprazole Magnesium
ANDA #210559
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Indchemie Health Labeling Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Padagis Us Labeling Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Padagis Us Labeling Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Padagis Us Labeling Approved
Itraconazole
ANDA #206741
Itraconazole Capsule; Oral SUPPL-14 Alembic Labeling Approved
Itraconazole
ANDA #206741
Itraconazole Capsule; Oral SUPPL-14 Alembic Labeling Approved
Itraconazole
ANDA #206741
Itraconazole Capsule; Oral SUPPL-14 Alembic Labeling Approved
Levetiracetam
ANDA #201157
Levetiracetam Solution; Oral SUPPL-8 Pharm Assoc Labeling Approved
Levetiracetam
ANDA #204312
Levetiracetam Injectable; Intravenous SUPPL-9 Eugia Pharma Labeling Approved
Levetiracetam
ANDA #211954
Levetiracetam Injectable; Intravenous SUPPL-2 Micro Labs Labeling Approved
Levetiracetam
ANDA #211954
Levetiracetam Injectable; Intravenous SUPPL-1 Micro Labs Labeling Approved
Levetiracetam
ANDA #211954
Levetiracetam Injectable; Intravenous SUPPL-2 Micro Labs Labeling Approved
Levoleucovorin Calcium
ANDA #217314
Levoleucovorin Calcium Solution; Intravenous ORIG-1 Hainan Poly Pharm Approved
Opvee
NDA #217470
Nalmefene Spray; Nasal ORIG-1 Opiant Pharmaceuticals Inc Type 3 - New Dosage Form Approved
Pemetrexed
NDA #215179
Pemetrexed Solution; Intravenous ORIG-1 Shilpa Medicare Ltd Type 5 - New Formulation or New Manufacturer Approved
Rydapt
NDA #207997
Midostaurin Capsule; Oral SUPPL-10 Novartis Labeling Approved
Vigabatrin
ANDA #214961
Vigabatrin For Solution; Oral SUPPL-2 Pyros Pharms Labeling Approved
Vigabatrin
ANDA #214961
Vigabatrin For Solution; Oral SUPPL-2 Pyros Pharms Labeling Approved
Vigabatrin
ANDA #214961
Vigabatrin For Solution; Oral SUPPL-2 Pyros Pharms Labeling Approved

May 19, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #207401
Acetazolamide Capsule, Extended Release; Oral SUPPL-1 Micro Labs Ltd India Labeling Approved
Acetazolamide
ANDA #207659
Acetazolamide Capsule, Extended Release; Oral SUPPL-3 Accord Hlthcare Labeling Approved
Aliskiren Hemifumarate
ANDA #206665
Aliskiren Hemifumarate Tablet; Oral SUPPL-2 Anchen Pharms Labeling Approved
Amitriptyline Hydrochloride
ANDA #217411
Amitriptyline Hydrochloride Tablet; Oral ORIG-1 Graviti Pharms Approved
Beyaz
NDA #022532
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium Tablet; Oral SUPPL-10 Bayer Hlthcare Labeling Approved
Carboprost Tromethamine
ANDA #216824
Carboprost Tromethamine Injectable; Injection ORIG-1 Welding Approved
Clozaril
NDA #019758
Clozapine Tablet; Oral SUPPL-103 Heritage Life Labeling Approved
Colchicine
ANDA #210425
Colchicine Tablet; Oral SUPPL-2 Granules Labeling Approved
Colchicine
ANDA #210425
Colchicine Tablet; Oral SUPPL-2 Granules Labeling Approved
Colchicine
ANDA #210425
Colchicine Tablet; Oral SUPPL-2 Granules Labeling Approved
Deferasirox
ANDA #209433
Deferasirox Tablet, For Suspension; Oral SUPPL-1 Ichnos Labeling Approved
Deferasirox
ANDA #209433
Deferasirox Tablet, For Suspension; Oral SUPPL-2 Ichnos Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-7 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-8 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-9 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-10 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-11 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-12 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-13 Sandoz Labeling Approved
Diclofenac Sodium and Misoprostol
ANDA #200158
Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-14 Sandoz Labeling Approved
Drospirenone and Ethinyl Estradiol
ANDA #205876
Drospirenone; Ethinyl Estradiol Tablet; Oral-28 SUPPL-3 Apotex Labeling Approved
Drospirenone and Ethinyl Estradiol
ANDA #205876
Drospirenone; Ethinyl Estradiol Tablet; Oral-28 SUPPL-6 Apotex Labeling Approved
Drospirenone and Ethinyl Estradiol
ANDA #205876
Drospirenone; Ethinyl Estradiol Tablet; Oral-28 SUPPL-3 Apotex Labeling Approved
Drospirenone and Ethinyl Estradiol
ANDA #205876
Drospirenone; Ethinyl Estradiol Tablet; Oral-28 SUPPL-6 Apotex Labeling Approved
Epkinly
BLA #761324
Epcoritamab-Bysp Injectable; Subcutaneous ORIG-1 Genmab Us, Inc. Type 1 - New Molecular Entity Approved
Lamotrigine
ANDA #200672
Lamotrigine Tablet, Extended Release; Oral SUPPL-13 Actavis Elizabeth Labeling Approved
Lamotrigine
ANDA #200672
Lamotrigine Tablet, Extended Release; Oral SUPPL-12 Actavis Elizabeth Labeling Approved
Lamotrigine
ANDA #200672
Lamotrigine Tablet, Extended Release; Oral SUPPL-13 Actavis Elizabeth Labeling Approved
Lamotrigine
ANDA #200672
Lamotrigine Tablet, Extended Release; Oral SUPPL-12 Actavis Elizabeth Labeling Approved
Lamotrigine
ANDA #200672
Lamotrigine Tablet, Extended Release; Oral SUPPL-13 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-15 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-12 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-13 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-14 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-15 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-11 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-12 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-13 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-14 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090263
Levetiracetam Solution; Oral SUPPL-15 Chartwell Molecular Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-7 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-6 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-7 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-8 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-9 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-5 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-6 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-7 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-8 Amneal Pharms Labeling Approved
Levetiracetam
ANDA #090992
Levetiracetam Solution; Oral SUPPL-9 Amneal Pharms Labeling Approved
Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
ANDA #205833
Moxifloxacin Hydrochloride Solution; Intravenous SUPPL-9 Mylan Labs Ltd Labeling Approved
Safyral
NDA #022574
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium Tablet; Oral SUPPL-10 Bayer Hlthcare Labeling Approved
Sevelamer Carbonate
ANDA #206094
Sevelamer Carbonate Tablet; Oral SUPPL-3 Dr Reddys Labeling Approved
Sevelamer Carbonate
ANDA #206094
Sevelamer Carbonate Tablet; Oral SUPPL-5 Dr Reddys Labeling Approved
Tetrabenazine
ANDA #206093
Tetrabenazine Tablet; Oral SUPPL-1 Apotex Labeling Approved
Tetrabenazine
ANDA #206093
Tetrabenazine Tablet; Oral SUPPL-1 Apotex Labeling Approved
Tetrabenazine
ANDA #206093
Tetrabenazine Tablet; Oral SUPPL-1 Apotex Labeling Approved
Yasmin
NDA #021098
Drospirenone; Ethinyl Estradiol Tablet; Oral-28 SUPPL-29 Bayer Hlthcare Labeling Approved
Yaz
NDA #021676
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-20 Bayer Hlthcare Labeling Approved
Zoledronic Acid
ANDA #202923
Zoledronic Acid Injectable; Intravenous SUPPL-14 Usv Labeling Approved
Zoledronic Acid
ANDA #202923
Zoledronic Acid Injectable; Intravenous SUPPL-7 Usv Labeling Approved
Zoledronic Acid
ANDA #202923
Zoledronic Acid Injectable; Intravenous SUPPL-14 Usv Labeling Approved

May 18, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-27 Sandoz Labeling Approved
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-20 Sandoz Labeling Approved
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-22 Sandoz Labeling Approved
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-25 Sandoz Labeling Approved
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-27 Sandoz Labeling Approved
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-29 Sandoz Labeling Approved
Clarithromycin
ANDA #065136
Clarithromycin Tablet; Oral SUPPL-25 Sandoz Labeling Approved
Clarithromycin
ANDA #065144
Clarithromycin Tablet; Oral SUPPL-19 Sandoz Labeling Approved
Clarithromycin
ANDA #065144
Clarithromycin Tablet; Oral SUPPL-21 Sandoz Labeling Approved
Clarithromycin
ANDA #065144
Clarithromycin Tablet; Oral SUPPL-24 Sandoz Labeling Approved
Clarithromycin
ANDA #065144
Clarithromycin Tablet; Oral SUPPL-26 Sandoz Labeling Approved
Clarithromycin
ANDA #065144
Clarithromycin Tablet; Oral SUPPL-28 Sandoz Labeling Approved
Clarithromycin
ANDA #065144
Clarithromycin Tablet; Oral SUPPL-24 Sandoz Labeling Approved
Cyltezo
BLA #761058
Adalimumab-Adbm Injectable; Injection SUPPL-16 Boehringer Ingelheim Efficacy Approved
Femhrt
NDA #021065
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-25 Apil Labeling Approved
Femhrt
NDA #021065
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-26 Apil Labeling Approved
Imbruvica
NDA #205552
Ibrutinib Capsule; Oral SUPPL-40 Pharmacyclics Inc Efficacy Approved
Imbruvica
NDA #210563
Ibrutinib Tablet; Oral SUPPL-17 Pharmacyclics Inc Efficacy Approved
Miebo
NDA #216675
Perfluorohexyloctane Solution/Drops; Ophthalmic ORIG-1 Bausch and Lomb Inc Type 1 - New Molecular Entity Approved
Naloxone Hydrochloride
ANDA #070639
Naloxone Hydrochloride Injectable; Injection SUPPL-19 Intl Medication Labeling Approved
Naloxone Hydrochloride
ANDA #070639
Naloxone Hydrochloride Injectable; Injection SUPPL-19 Intl Medication Labeling Approved
Phyrago
NDA #216099
Dasatinib Tablet; Oral ORIG-1 Nanocopoeia Llc Tentative Approval
Rinvoq
NDA #211675
Upadacitinib Tablet, Extended Release; Oral SUPPL-15 Abbvie Efficacy Approved
Venlafaxine Hydrochloride
ANDA #217390
Venlafaxine Hydrochloride Capsule, Extended Release; Oral ORIG-1 Granules Approved

May 17, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Briviact
NDA #205836
Brivaracetam Tablet; Oral SUPPL-14 Ucb Inc Labeling Approved
Briviact
NDA #205837
Brivaracetam Solution; Intravenous SUPPL-11 Ucb Inc Labeling Approved
Briviact
NDA #205837
Brivaracetam Solution; Intravenous SUPPL-11 Ucb Inc Labeling Approved
Briviact
NDA #205838
Brivaracetam Solution; Oral SUPPL-11 Ucb Inc Labeling Approved
Briviact
NDA #205838
Brivaracetam Solution; Oral SUPPL-11 Ucb Inc Labeling Approved
Clinolipid 20%
NDA #204508
Olive Oil; Soybean Oil Emulsion; Intravenous SUPPL-19 Baxter Hlthcare Corp Labeling Approved
Clinolipid 20%
NDA #204508
Olive Oil; Soybean Oil Emulsion; Intravenous SUPPL-19 Baxter Hlthcare Corp Labeling Approved
Clinolipid 20%
NDA #204508
Olive Oil; Soybean Oil Emulsion; Intravenous SUPPL-21 Baxter Hlthcare Corp Labeling Approved
Intralipid 10%
NDA #017643
Soybean Oil Injectable; Injection SUPPL-83 Fresenius Labeling Approved
Intralipid 20%
NDA #018449
Soybean Oil Injectable; Injection SUPPL-50 Fresenius Labeling Approved
Intralipid 20%
NDA #018449
Soybean Oil Injectable; Injection SUPPL-51 Fresenius Labeling Approved
Intralipid 20%
NDA #020248
Soybean Oil Injectable; Injection SUPPL-27 Fresenius Labeling Approved
Intralipid 20%
NDA #020248
Soybean Oil Injectable; Injection SUPPL-28 Fresenius Labeling Approved
Intralipid 30%
NDA #019942
Soybean Oil Injectable; Injection SUPPL-21 Fresenius Labeling Approved
Isosulfan Blue
ANDA #210294
Isosulfan Blue Injectable; Injection ORIG-1 Am Regent Approved
Kabiven In Plastic Container
NDA #200656
Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil Emulsion; Intravenous SUPPL-18 Fresenius Kabi Usa Labeling Approved
Levetiracetam
ANDA #090876
Levetiracetam Injectable; Intravenous SUPPL-3 Fresenius Kabi Usa Labeling Approved
Levetiracetam
ANDA #090876
Levetiracetam Injectable; Intravenous SUPPL-4 Fresenius Kabi Usa Labeling Approved
Nutrilipid 10%
NDA #019531
Soybean Oil Injectable; Injection SUPPL-16 B Braun Labeling Approved
Nutrilipid 10%
NDA #019531
Soybean Oil Injectable; Injection SUPPL-13 B Braun Manufacturing (CMC) Approved
Nutrilipid 20%
NDA #019531
Soybean Oil Injectable; Injection SUPPL-16 B Braun Labeling Approved
Nutrilipid 20%
NDA #019531
Soybean Oil Injectable; Injection SUPPL-13 B Braun Manufacturing (CMC) Approved
Omegaven
NDA #210589
Fish Oil Triglycerides Emulsion; Intravenous SUPPL-3 Fresenius Kabi Usa Labeling Approved
Perikabiven In Plastic Container
NDA #200656
Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil Emulsion; Intravenous SUPPL-18 Fresenius Kabi Usa Labeling Approved
Smoflipid 20%
NDA #207648
Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil Emulsion; Intravenous SUPPL-10 Fresenius Kabi Usa Labeling Approved
Spironolactone and Hydrochlorothiazide
ANDA #089534
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-49 Sun Pharm Industries Labeling Approved
Spironolactone and Hydrochlorothiazide
ANDA #089534
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-50 Sun Pharm Industries Labeling Approved
Spironolactone and Hydrochlorothiazide
ANDA #089534
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-55 Sun Pharm Industries Labeling Approved
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