ANDA Approvals

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

Fourth Quarter

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