ANDA Approvals

New Drug Applications and 505(b)(2) Applications

Fourth Quarter

GENERICally Speaking

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/1/2021 Bloxiverz Neostigmine Methylsulfate Exela Indoco
10/1/2021 Cancidas Caspofungin Acetate Merck UBI
10/1/2021 Mexitil Mexiletine HCl Boehringer-Ingelheim Havix
10/1/2021 Neurontin Gabapentin Upjohn Ascent Pharms
10/1/2021 Tamiflu Oseltamivir Phosphate Roche Epic
10/4/2021 Emend Fosaprepitant Dimeglumine Merck Praxgen
10/4/2021 Rhofade Cream, 1% Oxymetazoline HCl EPI Health Taro
10/5/2021 Diovan Valsartan Novartis Dr Reddy's
10/5/2021 Sinemet CR Carbidopa / Levodopa Organon ScieGen
10/6/2021 Imodium Loperamide HCl Johnson & Johnson Edenbridge
10/7/2021 Truvada Emtricitabine /  Tenofovir Disoproxil Fumarate Gilead Hetero
10/7/2021 Efudex Fluorouracil Bausch Accord
10/7/2021 Trisenox Arsenic Trioxide Teva Gland Pharma
10/8/2021 Cuprimine Penicillamine Bausch Navinta
10/8/2021 Cataflam Diclofenac Potassium Amici Riconpharma
10/12/2021 Istodax Romidepsin Celgene Fresenius Kabi
10/12/2021 Diprivan Propofol Fresenius Kabi Emcure
10/12/2021 Doxil Doxorubicin HCl Baxter Healthcare Ayana Pharma
10/12/2021 Mivacron Mivacurium Chloride AbbVie Woodward
10/13/2021 Robinul Glycopyrrolate Hikma Nivagen Pharms
10/13/2021 Carbaglu Carglumic Acid Recordati ANI
10/14/2021 Welchol Colesevelam HCl Daiichi Sankyo Beijing Tide Pharm
10/14/2021 Revlimid Lenalidomide Celgene Dr. Reddy's
10/14/2021 Cogentin Benztropine Mesylate Akorn Hikma
10/14/2021 Tikosyn Dofetilide Pfizer Granules
10/14/2021 Metrogel-Vaginal Metronidazole Bausch Solaris
10/14/2021 Decadron Dexamethasone Merck Amneal
10/15/2021 Trisenox Arsenic Trioxide Teva Eugia Pharma
10/15/2021 Pepcid Famotidine Bausch Ascent Pharms
10/18/2021 Zortress Everolimus Novartis Par
10/19/2021 Questran Light Cholestyramine Light Bristol-Myers Squibb Alkem Labs
10/19/2021 Questran Cholestyramine Bristol-Myers Squibb Alkem Labs
10/19/2021 Zipsor Diclofenac Potassium Assertio Aurobindo
10/19/2021 Quelicin Succinylcholine Chloride Hospira Hong Kong
10/20/2021 Soma Carisoprodol Mylan MLV
10/20/2021 Potassium Acetate Potassium Acetate Hospira Exela Pharma
10/20/2021 Permitil Fluphenazine HCl Schering Enaltec
10/20/2021 Mutamycin Mitomycin Bristol Gland Pharma
10/21/2021 Monurol Fosfomycin Tromethamine Zambon Alkem
10/22/2021 Imodium Loperamide HCl Johnson & Johnson Bionpharma
10/25/2021 Inspra Eplerenone Upjohn Westminster Pharms
10/25/2021 Mepron Atovaquone Glaxo Abon
10/25/2021 Librax Chlordiazepoxide HCl / Clidinium Bromide Bausch Amneal
10/25/2021 Tenoretic Atenolol / Chlorthalidone Almatica ANI
10/25/2021 Thorazine Chlorpromazine HCl Glaxo Teva
10/27/2021 Diovan Valsartan Novartis ScieGen
10/29/2021 Duexis Ibuprofen / Famotidine Horizon Teva
10/29/2021 Zebeta Bisoprolol Fumarate Teva Novitium Pharma
11/2/2021 Librax Chlordiazepoxide HCl / Clidinium Bromide Horizon Teva
11/2/2021 Fusilev Levoleucovorin Calcium Spectrum Praxgen
11/2/2021 CellCept Mycophenolate Mofetil Roche Amneal
11/3/2021 Lymphazurin Isosulfan Blue Mylan Hong Kong
11/3/2021 Zymaxid Gatifloxacin AbbVie Torrent
11/3/2021 Myfortic Mycophenolic Sodium Novartis Twi
11/3/2021 Pepcid AC Famotidine Johnson & Johnson Ascent Pharms
11/4/2021 Westcort Hydrocortisone Valerate Sun Encube
11/4/2021 Lyrica CR Pregabalin Pfizer Mylan
11/4/2021 Cialis Tadalafil Lilly VKT Pharma
11/4/2021 Ziac Bisoprolol Fumarate / Hydrochlorothiazide Teva Novitium Pharma
11/4/2021 Pepcid AC Famotidine Johnson & Johnson Annora Pharma
11/5/2021 Focalin XR Dexmethylphenidate HCl Novartis Sun
11/8/2021 Azactam Aztreonam Bristol-Myers Squibb Pfizer
11/8/2021 Magnesium Sulfate Magnesium Sulfate Hospira PTS Consulting
11/8/2021 Xylocaine Lidocaine HCl Fresenius Kabi Aspiro
11/8/2021 Pepcid AC Famotidine Johnson & Johnson Annora Pharma
11/9/2021 Brovana Arformoterol Tartrate Sunovion Teva
11/9/2021 Potassium Chloride / Dextrose Potassium Chloride / Dextrose ICU Medical Fresenius Kabi
11/9/2021 Androgel Testosterone AbbVie Encube
11/9/2021 Robinul Glycopyrrolate Robins AH Zydus
11/10/2021 Gilenya Fingolimod HCl Novartis HEC
11/10/2021 Baraclude Entecavir Bristol-Myers Squibb Yung Shin Pharm
11/10/2021 Miacalcin Calcitonin-Salmon Mylan Par
11/10/2021 Carnitor Levocarnitine Leadiant Saptalis
11/12/2021 Aloxi Palonosetron HCl Roche Baxter
11/12/2021 Gilenya Fingolimod HCl Novartis Teva
11/15/2021 Zovirax Acyclovir Bausch Prinston Inc
11/15/2021 Lovaza Omega-3-Acid Ethyl Esters Glaxo Mankind
11/16/2021 Bactroban Mupirocin Glaxo Alembic/Aleor
11/16/2021 Gabitril Tiagabine HCl Teva MSN
11/16/2021 Revatio Sildenafil Citrate Pfizer Taro
11/16/2021 Deltasone Prednisone Pharmacia / Upjohn Aurobindo
11/17/2021 Durezol Difluprednate Novartis Amneal
11/17/2021 Revatio Sildenafil Citrate Pfizer Tris
11/17/2021 Arranon Nelarabine Novartis Zydus
11/17/2021 Nizoral Ketoconazole Janssen Tasman Pharma
11/18/2021 Azilect Rasagiline Mesylate Teva Dr. Reddy's
11/19/2021 Isuprel Isoproterenol HCl Bausch Avet Lifesciences
11/19/2021 Jadenu Sprinkle Deferasirox Novartis Teva
11/19/2021 Dacogen Decitabine Otsuka Zydus
11/22/2021 Vibramycin Doxycycline Hyclate Pfizer Nesher Pharms
11/22/2021 Adderall Amphetamine / Dextroamphetamine Teva Accord Healthcare
11/22/2021 Niaspan Niacin AbbVie Beijing
11/22/2021 Perforomist Formoterol Fumarate Mylan Alembic
11/22/2021 Digoxin Digoxin Concordia ANI / Novitium
11/23/2021 Focalin XR Dexmethylphenidate HCl Novartis IntelliPharmaceutics
11/23/2021 Sprycel Dasatinib Bristol-Myers Squibb Apotex
11/23/2021 Afinitor Everolimus Novartis Hikma
11/23/2021 Isordil Isosorbide Dinitrate Bausch Par
11/23/2021 Temodar Temozolomide Merck Sharp Dohme Nivagen Pharms
11/23/2021 Cystadone Betaine Orphan Europe ANI
11/26/2021 Zortress Everolimus Novartis Alkem Labs Ltd
11/26/2021 Adderall XR Amphetamine / Dextroamphetamine Takeda Lannett Co Inc
11/26/2021 Cubicin Daptomycin Cubist Pharms Hangzhou Zhongmei
11/26/2021 Atropine Sulfate Atropine Sulfate Akorn Apotex
11/29/2021 Myfortic Mycophenolic Acid Novartis Bionpharma
11/30/2021 Amitiza Lubiprostone Takeda Amneal
11/30/2021 Sutent Sunitinib Malate Pfizer Teva
12/1/2021 Abilify Aripiprazole Bristol-Myers Squibb Unichem
12/1/2021 Atropine Sulfate Atropine Sulfate Fresenius Kabi Hikma
12/2/2021 Sensipar Cinacalcet HCl Amgen Amneal
12/2/2021 Ravicti Glycerol Phenylbutyrate Horizon Par
12/2/2021 Trisenox Arsenic Trioxide Teva Sandoz
12/3/2021 Glucophage Metformin HCl EMD Serono Harman Finochem
12/6/2021 Sutent Sunitinib Malate Pfizer Mylan
12/7/2021 Uloric Febuxostat Takeda Alkem
12/8/2021 Thioplex Thiotepa Amgen Beloteca
12/8/2021 Lamictal XR Lamotrigine Glaxo Yiling
12/8/2021 Focalin XR Dexmethylphenidate HCl Novartis Hetero
12/9/2021 NuvaRing Ethinyl Estradiol / Etonogestrel Merck Dr. Reddy's
12/13/2021 Timoptic in Ocudose Timolol Maleate Bausch IndentiRx
12/13/2021 Glumetza Metformin HCl Bausch Apotex
12/13/2021 Advair Diskus Fluticasone Propionate / Salmeterol Xinafoate Glaxo Teva
12/14/2021 AmBiosone Amphotericin B Astellas Sun
12/15/2021 Vasostrict Vasopressin Endo / Par Eagle
12/17/2021 Bystolic Nebivolol HCl AbbVie Cadila Pharms
12/17/2021 Bystolic Nebivolol HCl AbbVie Aurobindo
12/17/2021 Bystolic Nebivolol HCl AbbVie Reyoung
12/17/2021 Mycobutin Rifabutin Pfizer ANI
12/21/2021 Periactin Cyproheptadine HCl Merck Tris Pharma
12/21/2021 Tecfidera Dimethyl Fumarate Biogen Sawai
12/22/2021 Depacon Valproate Sodium AbbVie Mylan
12/22/2021 Atripla Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Laurus
12/23/2021 Renagel Sevelamer Carbonate Genzyme Lupin
12/23/2021 Minipress Prazosin HCl Pfizer Granules
12/27/2021 Cerdelga Eliglustat Tartrate Genzyme Teva
12/27/2021 Rapamune Sirolimus Pfizer Torrent
12/28/2021 AccuNeb Albuterol Sulfate Mylan RiteDose
12/28/2021 Adderall Amphetamine / Dextroamphetamine Teva Granules
12/30/2021 Corlanor Ivabradine HCl Amgen Centaur Pharms
GENERICally Speaking Hatch Waxman Bulletin

Related Professionals

Oren D. Langer

Partner

Managing Partner, New York Office

Jeffrey Alan Hovden

Partner

Christopher A. Pinahs

Partner

RELATED SERVICES

Hatch-Waxman Litigation
GENERICally Speaking Hatch Waxman Bulletin
READ MORE

Related Publications

First Quarter
ANDA Litigation Settlements
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
New ANDA Cases
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
ANDA Approvals
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
Generic Launches
GENERICally Speaking Hatch Waxman Bulletin
March 22, 2022
Genentech, Inc. v. Sandoz, Inc.
GENERICally Speaking Hatch Waxman Bulletin
VIEW ALL

Related News

March 7, 2022
Robins Kaplan Attorneys Earn 2022 Readers' Choice Awards from JD Supra
October 26, 2021
Robins Kaplan Named “Recommended Firm” For Hatch-Waxman Litigation in 2021
August 2, 2021
Jake Holdreith Shortlisted by LMG Life Sciences for Hatch-Waxman Litigator of the Year
March 31, 2021
Robins Kaplan Attorneys Earn 2021 Readers' Choice Awards from JD Supra
October 12, 2020
Robins Kaplan Named “Recommended Firm” for Hatch-Waxman Litigation; Four Partners “life Sciences Stars”
VIEW ALL
Back to Top