ANDA Approvals Summer 2020 | Hatch-Waxman | Robins Kaplan LLP Law Firm

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

Summer 2020

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
04/01/2020	Nexium	esomeprazole sodium	AstraZeneca	Gland Pharma
04/01/2020	Lamictal XR	lamotrigine	GlaxoSmithKline	Zydus
04/01/2020	Crestor	rosuvastatin calcium	AstraZeneca	Sunshine Lake
04/02/2020	heparin sodium preservative free	heparin sodium preservative free	Fresenius Kabi	Nanjing King-Friend
04/03/2020	Adderall	dextroamp saccharate / amp aspartate / dextroamp sulfate / amp sulfate	Teva	Bionpharma
04/03/2020	Anafril	clomipramine HCl	SpecGx	Tulex Pharms
04/03/2020	Namenda	memantine HCl	Allergan	Ningbo
04/06/2020	Trilafon	perphenazine	Schering	Zydus
04/06/2020	Brilinta	ticagrelor	AstraZeneca	Hec Pharm
04/06/2020	Questran	cholestyramine	Bristol-Myers Squibb	Ajanta Pharma
04/06/2020	Ditropan	oxybutynin chloride	Janssen	Leading Pharma
04/07/2020	Brilinta	ticagrelor	AstraZeneca	Sigmapharm Labs
04/07/2020	Minastrin 24 FE	ethinyl estradiol / norethindrone acetate	Allergan	Teva
04/07/2020	Zovirax	acyclovir	Bausch & Lomb	Solaris Pharma
04/07/2020	Elavil	amitriptyline HCl	AstraZeneca	Upsher Smith Labs
04/07/2020	Plaquenil	hydroxychloroquine sulfate	Advanz	Accord Healthcare
04/08/2020	Proventil HFA	albuterol sulfate	Merck	Cipla
04/08/2020	Eliquis	apixaban	Bristol-Myers Squibb	Bionpharma
04/08/2020	Gleevec	imatinib mesylate	Novartis	Zydus
04/08/2020	Prozac	fluoxetine HCl	Eli Lilly	Aurobindo
04/08/2020	butalbital / acetaminophen / caffeine	butalbital / acetaminophen / caffeine	Nexgen	Granules Pharms
04/08/2020	Hydera	hydroxyurea	Bristol-Myers Squibb	Leading Pharma
04/09/2020	Naropin	ropivacaine HCl	Fresenius Kabi	Caplin
04/09/2020	Renvela	sevelamer carbonate	Genzyme	Anxin
04/09/2020	Glumetza	metformin HCl	Santarus	Ajanta Pharma
04/10/2020	Methylin	methylphenidate HCl	SpecGx	Patrin Pharma
04/10/2020	Rozarem	ramelteon	Takeda	I3 Pharms
04/13/2020	Benicar	olmesartan medoxomil	Daiichi Sankyo	Sandoz
04/13/2020	Soolantra	ivermectin	Galderma	Perrigo
04/13/2020	Vesicare	solifenacin succinate	Astellas	Sunshine Lake
04/13/2020	Aromasin	exemestane	Pfizer	Qilu
04/14/2020	Butrans	buprenorphine	Purdue	Amneal
04/15/2020	Estrostep FE	ethinyl estradiol / norethindrone acetate	Allergan	Novast Labs
04/15/2020	Tegretol	carbamazepine	Novartis	Umedica Labs
04/16/2020	Androgel	testosterone	AbbVie	Xiromed
04/16/2020	Tarceva	erlotinib HCl	OSI Pharma	Zydus
04/17/2020	Wellbutrin	bupropion HCl	GlaxoSmithKline	Micro Labs
04/17/2020	Suboxone	buprenorphine HCl / naloxone HCl	Indivior	Mylan
04/17/2020	Ancoban	flucytosine	Bausch & Lomb	Strides Pharma
04/17/2020	Bromfed DM	brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide	Wockhardt	Lannett
04/20/2020	AccuNeb	albuterol sulfate	Mylan	Aurobindo
04/20/2020	Welchol	colesevelam HCl	Daiichi Sankyo	Invagen Pharms
04/21/2020	Delestrogen	estradiol valerate	Par	Hikma
04/21/2020	Cloderm	clocortolone pivalate	EPI	Taro
04/22/2020	Levaquin	levofloxacin	Janssen	Gland Pharma
04/22/2020	Dilaudid	hydromorphone HCl	Rhodes	Lannett
04/23/2020	Viagra	sildenafil citrate	Pfizer	Perrigo
04/23/2020	Sodium Chloride	sodium chloride 0.9% in plastic container	Hospira	Nephron
04/23/2020	Zovirax	acyclovir	Bausch & Lomb	Heritage Pharms
04/23/2020	Sanctura XR	trospium chloride	Allergan	Granules Pharms
04/24/2020	Jadenu	deferasirox	Novartis	Teva
04/24/2020	Tegretol XR	carbamazepine	Novartis	Unique Pharm
04/24/2020	Adrenalin	epinephrine	Par	Intl Medication Sys
04/24/2020	Onfi	clobazam	Lundbeck	Lannett
04/24/2020	Sabril	vigabatrin	Lundbeck	Granules Pharms
04/27/2020	Bactroban	mupirocin	GlaxoSmithKline	Taro
04/27/2020	Xeloda	capecitabine	Hoffmann LaRoche	Reliance Life
04/28/2020	Tiazac	diltiazem HCl	Bausch & Lomb	Accord Healthcare
04/28/2020	Mucinex D	guaifenesin / pseudoephedrine HCl	Reckitt Benckiser	Sun Pharm Inds
04/28/2020	Cuprimine	penicillamine	Bausch	Apotex
04/29/2020	oxycodone HCl	oxycodone HCl	Genus Life	Rhodes Pharms
04/29/2020	Xyzal Allergy 24HR	levocetirizine dihydrochloride	UCB	Hetero Labs
04/30/2020	Diamox	acetazolamide	Teva	Breckenridge
04/30/2020	Lidoderm	lidocaine	Teikoku Pharma USA	Rhodes Pharms
04/30/2020	Zegerid	omeprazole / sodium bicarbonate	Bayer	Guardian Drug
05/01/2020	Methergine	methylergonovine maleate	Edison Therapeutics	Tulex Pharms
05/01/2020	Minocycline HCl	minocycline HCl	Triax Pharma	Aurobindo
05/01/2020	Ancoban	flucytosine	Bausch & Lomb	Aurobindo
05/04/2020	Nimbex	cisatracurium besylate	AbbVie	Piramal Healthcare
05/04/2020	Nexium 24HR	esomeprazole magnesium	AstraZeneca	Sun Pharm
05/04/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Aspiro
05/05/2020	Exjade	deferasirox	Novartis	Zydus
05/06/2020	Pradaxa	dabigatran etexilate mesylate	BI	Hetero Labs
05/06/2020	Sklice	ivermectin	Arbor	Taro
05/07/2020	Xylocaine	lidocaine HCl	Fresenius Kabi	Huons
05/08/2020	Actigall	ursodiol	Allergan	Nexgen Pharma
05/08/2020	Nimbex	cisatracurium besylate	AbbVie	Aurobindo
05/08/2020	Alkeran	melphalan HCl	Apotex	Bpi Labs
05/08/2020	Zithromax	azithromycin	Pfizer	Yung Shin Pharm
05/08/2020	Astelin	azelastine HCl	Mylan	Aurobindo
05/08/2020	Klor-Con	potassium chloride	Upsher-Smith	Amneal
05/08/2020	Mucinex	guaifenesin	Reckitt Benckiser	Granules India
05/08/2020	Motrin	ibuprofen	McNeil	Aurobindo
05/11/2020	Desonate	desonide	Bayer	Teresina
05/11/2020	Taclonex	calcipotriene / betamethasone dipropionate	LEO Pharma	Tolmar
05/11/2020	Luvox CR	fluvoxamine maleate	Elan	Bionpharma
05/12/2020	Lovaza	omega-3-acid ethyl esters	GlaxoSmithKline	Cspc Nbp Pharm
05/13/2020	Elyxb	celecoxib	Dr. Reddy's	Nanjing
05/14/2020	Vibra Tabs	doxycycline hyclate	Pfizer	Alembic Pharms
05/14/2020	Nexium 24HR OTC	esomeprazole magnesium	AstraZeneca	Dr Reddy's
05/14/2020	Nicorette	nicotine polacrilex	GlaxoSmithKline	P and L
05/14/2020	Symfi/Symfi Lo	efavirenz / lamivudine / tenofovir disoproxil fumarate	Mylan	Laurus Labs
05/14/2020	Plaquenil	hydroxychloroquine sulfate	Advanz	Havix
05/14/2020	Proventil	albuterol sulfate	Schering	Aurobindo
05/15/2020	Truvada	emtricitabine / tenofovir disoproxil fumarate	Gilead	Macleods Pharms
05/15/2020	Noxafil	posaconazole	Hikma	Hikma
05/15/2020	Sensipar	cinacalcet HCl	Amgen	Accord Healthcare
05/18/2020	Prevacid	lansoprazole	Takeda	Hetero Labs
05/18/2020	Gilenya	fingolimod HCl	Novartis	Hetero Labs
05/18/2020	Zytiga	abiraterone acetate	J&J	Dr Reddy's
05/18/2020	Benicar	olmesartan medoxomil	Daiichi Sankyo	Inventia
05/18/2020	Clobex	clobetasol propionate	Galderma	Aleor Dermaceuticals
05/18/2020	Sensipar	cinacalcet HCl	Amgen	Acme Labs
05/19/2020	Samsca	tolvaptan	Otsuka	Apotex
05/19/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Nivagen Pharms
05/19/2020	Samsca	tolvaptan	Otsuka	Alkem Labs
05/19/2020	Detrol LA	tolterodine tartrate	Pfizer	Ajanta Pharma
05/20/2020	Precedex	dexmedetomidine HCl	Hospira	Amneal
05/20/2020	Pataday	olopatadine HCl	Novartis	Gland Pharma
05/20/2020	Baraclude	entecavir	Bristol-Myers Squibb	Sunshine Lake
05/20/2020	Tamiflu	oseltamivir phosphate	Roche	MSN
05/20/2020	Migranal	dihydroergotamine mesylate	Bausch	Cipla
05/20/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Accord Healthcare
05/21/2020	Vascepa	icosapent ethyl	Amarin	Hikma
05/21/2020	Syprine	trientine HCl	Bausch & Lomb	Lupin
05/21/2020	Symmetrel	amantadine HCl	Endo Pharma	Rubicon
05/22/2020	Aloxi	palonosetron HCl	Helsinn	Ingenus Pharms
05/22/2020	Remodulin	treprostinil	United Therapeutics	Dr Reddy's
05/22/2020	Bentyl	dicyclomine HCl	Aptalis	Hikma
05/22/2020	Evekeo	amphetamine sulfate	Arbor	Havix
05/22/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Indoco Remedies
05/26/2020	Chlorzoxazone	chlorzoxazone	Mikart	Glenmark Pharms
05/27/2020	Tamiflu	oseltamivir phosphate	Gilead	Ajanta Pharma
05/27/2020	Zanaflex	tizanidine HCl	Covis Pharma	Rubicon
05/28/2020	Cosopt	dorzolamide HCl / timolol maleate	Oak Pharma	Micro Labs
05/28/2020	Nexium 24HR OTC	esomeprazole magnesium	AstraZeneca	Hetero Labs
05/29/2020	Revatio	sildenafil citrate	Pfizer	Teva
06/01/2020	Alaway/Zaditor	ketotifen fumarate	Bausch/Novartis	Bayshore Pharms
06/01/2020	Prilosec OTC	omeprazole magnesium	AstraZeneca	P and L
06/01/2020	Vivlodex	meloxicam	iCeutica	Lupin
06/01/2020	Reyataz	atazanavir sulfate	Bristol-Myers Squibb	Amneal
06/01/2020	Acticlate	doxycycline hyclate	Almirall	Ajanta Pharma
06/01/2020	Magnesium Sulfate	magnesium sulfate in plastic container	Hospira	Baxter Healthcare
06/01/2020	Triamcinolone 0.05% ointment	triamcinolone acetonide	CMP	Strides Pharma
06/02/2020	Unipen	nafcillin sodium	Wyeth	Fresenius Kabi USA
06/02/2020	Nexium	esomeprazole magnesium	AstraZeneca	Hetero Labs
06/02/2020	Uloric	febuxostat	Takeda	Sunshine Lake
06/03/2020	Precedex	dexmedetomidine HCl	Hospira	Gland Pharma
06/03/2020	Lomotil	diphenoxylate HCl / atropine sulfate	Pfizer	Mayne Pharma
06/03/2020	Ultravate lotion 0.05%	halobetasol propionate	Sun	Perrigo
06/04/2020	Reyataz	atazanavir sulfate	Bristol-Myers Squibb	Zydus
06/04/2020	Methylin	methylphenidate HCl	SpecGx	Quagen
06/04/2020	Ambien CR	zolpidem tartrate	Sanofi	Centaur Pharms
06/05/2020	Hexadrol	dexamethasone sodium phosphate	Aspen Global	Aurobindo
06/05/2020	Vazculep	phenylephrine HCl	Avadel	Gland Pharma
06/08/2020	Afinitor	everolimus	Novartis	Hikma
06/08/2020	Vidaza	azacitidine	Celgene	Eurohealth Intl
06/08/2020	Afinitor	everolimus	Novartis	Mylan
06/08/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Amphastar Pharms
06/09/2020	Edecrin	ethacrynate sodium	Bausch	VPI Pharms
06/09/2020	Onfi	clobazam	Lundbeck	Apotex
06/10/2020	Albenza	albendazole	Amneal	Lupin
06/10/2020	Prozac	fluoxetine hydrochloride	Eli Lilly	Aurobindo
06/11/2020	Keppra XR	levetiracetam	UCB	Overseas
06/11/2020	Viagra	sildenafil citrate	Pfizer	Sunshine Lake
06/11/2020	Vazculep	phenylephrine hydrochloride	Avadel	Caplin
06/12/2020	Viagra	sildenafil citrate	Pfizer	Reyoung
06/12/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Hikma
06/12/2020	Tricor	fenofibrate	AbbVie	Mankind Pharma
06/15/2020	Lovaza	omega-3-acid ethyl esters	GlaxoSmithKline	Puracap Pharm
06/15/2020	Jadenu	deferasirox	Novartis	Amneal
06/15/2020	Jadenu	deferasirox	Novartis	Zydus
06/15/2020	Jadenu	deferasirox	Novartis	Sun Pharm
06/15/2020	Jadenu	deferasirox	Novartis	Alembic Pharms
06/15/2020	Jadenu	deferasirox	Novartis	Cipla
06/15/2020	Jadenu	deferasirox	Novartis	Piramal Healthcare
06/16/2020	Targretin	bexarotene	Bausch & Lomb	Hikma
06/16/2020	Pataday	olopatadine HCl	Novartis	Micro Labs
06/16/2020	Jadenu	deferasirox	Novartis	MSN
06/16/2020	Bromfed DM	brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide	Wockhardt	Wes Pharma
06/16/2020	Meticorten	prednisone	Schering	Amneal
06/16/2020	Trilipix	fenofibric acid	Novartis	Micro Labs
06/16/2020	Anectine/Quelicin	succinylcholine chloride	Hospira/Sandoz	Gland Pharma
06/17/2020	Zovirax	acyclovir sodium	GlaxoSmithKline	Exela Pharma Scs
06/17/2020	Aubagio	teriflunomide	Sanofi	Impax
06/17/2020	Sernivo	betamethasone dipropionate	Encore	Taro Pharms
06/17/2020	Parafone Forte	chlorzoxazone	J&J	Teva
06/18/2020	Gilenya	fingolimod HCl	Novartis	Glenmark
06/18/2020	Firazyr	icatibant acetate	Shire	Fresenius Kabi USA
06/18/2020	Rythmol SR	propafenone HCl	Glaxo	Twi
06/18/2020	Differin	adapalene	Galderma	Aleor Dermaceuticals
06/19/2020	Cotempla XR ODT	methylphenidate	Neos	Actavis
06/19/2020	Brethine	terbutaline sulfate	ANI	Twi
06/19/2020	Tikosyn	dofetilide	Pfizer	Accord Hlthcare
06/22/2020	Anafril	clomipramine HCl	SpecGx	Micro Labs
06/22/2020	Anafril	clomipramine HCl	SpecGx	Vgyaan
06/23/2020	Lipitor	atorvastatin calcium	Pfizer	Perrigo
06/23/2020	Antivert	meclizine HCl	Casper	Zydus
06/24/2020	Adderall	dextroamp saccharate / amp aspartate / dextroamp sulfate / amp sulfate	Shire	Mylan
06/24/2020	Deltasone	prednisone	Pharmacia and Upjohn	Amneal
06/25/2020	Amoxil	amoxicillin	Neopharma	Hikma
06/25/2020	Nexium 24HR OTC	esomeprazole magnesium	AstraZeneca	Mylan
06/25/2020	Rythmol SR	propafenone HCl	Glaxo	Upsher Smith Labs
06/26/2020	Cytarabine	cytarabine	Hospira	Hong Kong
06/29/2020	Kytril	granisetron HCl	Hoffmann LaRoche	Yung Shin Pharm
06/29/2020	Gilenya	fingolimod HCl	Novartis	Strides Pharma
06/29/2020	Urocit K	potassium citrate	Mission	Bionpharma
06/30/2020	Acticlate	doxycycline hyclate	Almirall	Alembic Pharms
06/30/2020	Protonix	pantoprazole sodium	Wyeth	Sun Pharm