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

Fall 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
07/01/2020	butalbital / acetaminophen / caffeine	butalbital / acetaminophen / caffeine	LGM Pharma	Taro Pharm
07/01/2020	Sinequan	doxepin HCl	Pfizer	Taro Pharm
07/01/2020	Vazculep	phenylephrine HCl	Avadel	Accord Hlthcare
07/01/2020	Levo-Dromoran	levorphanol tartrate	Valeant	Novitium Pharma
07/01/2020	Kenalog	triamcinolone acetonide	Delcor	Quagen
07/01/2020	Furosemide	furosemide	Amercian Regent	Gland Pharma
07/02/2020	Gilenya	fingolimod HCl	Novartis	Teva
07/02/2020	Jadenu	deferasirox	Novartis	Alkem Labs
07/02/2020	Tarceva	erlotinib HCl	Genentech	Accord Healthcare
07/06/2020	Ampyra	dalfampridine	Acorda	Mylan
07/06/2020	Diclegis	doxylamine succinate / pyridoxine HCl	Duchesnay	Mylan
07/06/2020	Isoptin	verapamil HCl	Mt Adams	Aurobindo
07/06/2020	Flexeril	cyclobenzaprine HCl	Johnson & Johnson	Unichem
07/06/2020	Levetiracetam in Sodium Chloride	levetiracetam in sodium chloride	HQ Specialty	Nexus Pharms
07/07/2020	Effient	prasugrel	Eli Lilly	Dr Reddys
07/07/2020	Librax	chlordiazepoxide HCl / clidinium bromide	Bausch & Lomb	Nuvo Pharms
07/07/2020	Thorazine	chlorpromazine HCl	Glaxo	Aurobindo
07/08/2020	Fioricet with codeine	butalbital / acetaminophen / caffeine / codeine phosphate	Teva	Strides
07/08/2020	Proglycem	diazoxide	Teva	Novitium Pharma
07/08/2020	Robinul	glycopyrrolate	Hikma	Accord Healthcare
07/09/2020	Lyrica	pregabalin	Pfizer	Actavis
07/09/2020	Duoneb	albuterol sulfate / ipratropium bromide	Mylan	Aurobindo
07/09/2020	Lioresal	baclofen	Novartis	Unichem
07/09/2020	Ziac	bisoprolol fumarate / hydrochlorothiazide	Teva	Edenbridge Pharms
07/09/2020	Permitil	fluphenazine HCl	Schering	Amneal
07/10/2020	Zovirax	acyclovir	Mylan	Novitium Pharma
07/10/2020	Magnesium Sulfate in Plastic Container	magnesium sulfate in plastic container	Hospira	Gland Pharma
07/13/2020	Relpax	eletriptan hydrobromide	Upjohn	Yung Shin Pharm
07/13/2020	Firazyr	icatibant acetate	Shire	Cipla
07/14/2020	Bromfed DM	brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide	Wockhardt	Alkem Labs
07/14/2020	Mykacet	nystatin / triamcinolone acetonide	Cossette	Torrent
07/14/2020	Jadenu Sprinkle	deferasirox	Novartis	Alkem Labs
07/14/2020	Evekeo	amphetamine sulfate	Arbor	Mayne Pharma
07/14/2020	Betamethasone Dipropionate	betamethasone dipropionate	Fougera	Cadila
07/15/2020	Welchol	colesevelam HCl	Daiichi Sankyo	Zhejiang Jingxin
07/15/2020	Heparin Sodium	heparin sodium	West-Ward	Nanjing King-Friend
07/16/2020	Percodan	oxycodone and aspirin	Endo	Epic Pharma
07/16/2020	Primacor in Dextrose 5% in Plastic Container	milrinone lactate in dextrose 5% in plastic container	Sanofi Aventis	Gland Pharma
07/17/2020	Suboxone	buprenorphine HCl / naloxone HCl	Indivior	Mayne Pharma
07/17/2020	Suboxone	buprenorphine HCl / naloxone HCl	Indivior	Wes Pharma
07/17/2020	Vazculep	phenylephrine HCl	Avadel	Apollo
07/17/2020	butalbital / acetaminophen / caffeine	butalbital / acetaminophen / caffeine	Vintage	Nesher Pharms
07/17/2020	Plavix	clopidogrel bisulfate	Bristol-Myers Squibb	Polygen Pharms
07/20/2020	Oxacillin Sodium	oxacillin sodium	Bristol-Myers Squibb	Fresenius Kabi
07/20/2020	Naropin	ropivacaine HCl	Fresenius Kabi	Hikma
07/20/2020	Wynzora	betamethasone dipropionate / calcipotriene	MC2 Therapeutics	MC2 Therapeutics
07/21/2020	Parafone Forte	chlorzoxazone	Mikart	Mayne Pharma
07/21/2020	Maxipime	cefepime HCl	Hospira	Astral
07/21/2020	Cordarone	amiodarone HCl	Wyeth	Unichem
07/22/2020	Mexitil	mexiletine HCl	Boehringer Ingelheim	Crossmedika
07/23/2020	Ritalin	methylphenidate HCl	Novartis	Prinston Inc
07/23/2020	Gleevec	imatinib mesylate	Novartis	Eugia Pharma
07/24/2020	Silenor	doxepin HCl	Currax	Par
07/24/2020	Arimidex	anastrozole	ANI	Eugia Pharma
07/24/2020	Heparin Sodium 1,000 units in Sodium Chloride 0.9% in Plastic Container	heparin sodium 1,000 units in sodium chloride 0.9% in plastic container	Hospira	Fresenius Kabi
07/24/2020	Heparin Sodium 2,000 units in Sodium Chloride 0.9% in Plastic Container	heparin sodium 2,000 units in sodium chloride 0.9% in plastic container	Hospira	Fresenius Kabi
07/24/2020	Sinequan	doxepin HCl	Pfizer	Lannett
07/24/2020	Demser	metyrosine	Bausch & Lomb	Amneal
07/27/2020	Oxacillin Sodium	oxacillin sodium	Bristol-Myers Squibb	Fresenius Kabi
07/28/2020	Eliquis	apixaban	Bristol-Myers Squibb	Accord Healthcare
07/28/2020	Sinequan	doxepin hydrochloride	Pfizer	Contract Pharmacal
07/29/2020	Tasmar	tolcapone	Bausch & Lomb	Alvogen
07/29/2020	Librax	chlordiazepoxide HCl / clidinium bromide	Bausch & Lomb	Misemer
07/29/2020	Cleocin T	clindamycin phosphate	Pfizer	Solaris Pharma
07/29/2020	Concerta	methylphenidate HCl	Johnson & Johnson	Dr Reddys
07/30/2020	Wellcovorin	leucovorin calcium	Glaxo	Novast Labs
07/30/2020	Cyclophosphamide	cyclophosphamide	Ingenus	Ingenus
07/31/2020	Zyprexa	olanzapine	Eli Lilly	Indoco
07/31/2020	CellCept	mycophenolate mofetil	Roche	Concord Biotech
07/31/2020	Naprosyn	naproxen	Atnahs Pharma	Amneal
08/03/2020	Korlym	mifepristone	Corcept	Teva
08/03/2020	Metro I.V.	metronidazole in plastic container	B. Braun	Gland Pharma
08/03/2020	Vasostrict	vasopressin	Par	American Reagent
08/04/2020	Akovaz	ephedrine sulfate	Exela	Fresenius Kabi
08/04/2020	Cuprimine	penicillamine	Bausch & Lomb	Dr Reddys
08/04/2020	Nicorette	nicotine polacrilex	Glaxo	Dr Reddys
08/04/2020	Levitra	vardenafil HCl	Bayer	Alembic Pharms
08/05/2020	Renvela	sevelamer carbonate	Genzyme	Mylan
08/05/2020	Detrol	tolterodine tartrate	Novartis	Unichem
08/06/2020	Zavesca	miglustat	Actelion	Edenbridge Pharms
08/06/2020	Revatio	sildenafil citrate	Pfizer	Aptapharma
08/07/2020	Faslodex	fulvestrant	AstraZeneca	Dr Reddys
08/07/2020	Vascepa	icosapent ethyl	Amarin	Dr Reddys
08/07/2020	Anafranil	clomipramine HCl	SpecGx	Unique Pharm Labs
08/07/2020	Ofirmev	acetaminophen	Mallinckrodt	Mylan
08/10/2020	Ciprodex	ciprofloxacin / dexamethasone	Novartis	Dr Reddys
08/10/2020	Baraclude	entecavir	Bristol-Myers Squibb	Pharmadax
08/10/2020	Inspra	eplerenone	Pfizer	Piramal
08/10/2020	Proamatine	midodrine HCl	Takeda	Aurobindo
08/11/2020	Vancomycin HCl	vancomycin HCl	Baxter	Hikma
08/11/2020	Renvela	sevelamer carbonate	Genzyme	Zydus
08/11/2020	Magnesium Sulfate in Dextrose 5% in Plastic Container	magnesium sulfate in dextrose 5% in plastic container	Hospira	Baxter
08/11/2020	Amicar	aminocaproic acid	Clover	Tulex Pharms
08/12/2020	Robaxin-750	methocarbamol	Auxiluim	Aurobindo
08/13/2020	Stalevo	carbidopa / levodopa / entacapone	Novartis	Mylan
08/14/2020	Canasa	mesalamine	Allergan	Actavis
08/14/2020	Nolvadex	tamoxifen citrate	AstraZeneca	Eugia Pharma
08/17/2020	Alesse	levonorgestrel / ethinyl estradiol	Cadence	Naari PTE
08/17/2020	Tecfidera	dimethyl fumarate	Biogen	Mylan
08/17/2020	Actigall	ursodiol	Allergan	Upsher Smith
08/17/2020	Neurontin	gabapentin	Upjohn	Zhejiang Yongtai
08/18/2020	Evista	raloxifene HCl	Eli Lilly	Cadila Pharms
08/18/2020	Farston	toremifene citrate	Kyowa Kirin	MSN
08/18/2020	Precose	acarbose	Bayer	Hangzhou Zhongmei
08/19/2020	Concerta	methylphenidate HCl	Johnson & Johnson	Sun
08/19/2020	Lovaza	omega-3-acid ethyl esters	SmithKline Beecham	GLW
08/19/2020	Patanase	olopatadine HCl	Novartis	Akorn
08/19/2020	Lipitor	atorvastatin calcium	Upjohn	Umedica Labs
08/20/2020	Torodol	ketorolac tromethamine	Roche	Nephron
08/20/2020	Emend	fosaprepitant dimeglumine	Merck	Navinta
08/20/2020	Daptomycin	daptomycin	Xellia	Be Pharms
08/20/2020	Urso/Urso Forte	ursodiol	Allergan	Strides
08/21/2020	Rozarem	ramelteon	Takeda	Granules Pharms
08/21/2020	Klor-Con	potassium chloride	Upsher-Smith	Unichem
08/21/2020	Alimta	pemetrexed	Eli Lilly	Teva
08/24/2020	Lidoderm patch	lidocaine	Endo	Amneal
08/24/2020	ProAir HFA	albuterol sulfate	Teva	Lupin
08/24/2020	Taxol	paclitaxel	HQ Specialty	MSN
08/24/2020	DesOwen 0.05% lotion	desonide	Galderma	Aleor Dermaceuticals
08/24/2020	Evekeo	amphetamine sulfate	Arbor	Novast Labs
08/25/2020	Viagra	sildenafil citrate	Pfizer	Umedica Labs
08/25/2020	Nitropress	sodium nitroprusside	Hospira	Hainan Poly Pharm
08/26/2020	Emend	fosaprepitant dimeglumine	Merck	Accord Healthcare
08/26/2020	Dextrose 5% and Sodium Chloride 0.3% in Plastic Container	dextrose 5% and sodium chloride 0.3% in plastic container	ICU Medical	Fresenius Kabi
08/27/2020	Prozac	fluoxetine HCl	Eli Lilly	Accord Healthcare
08/27/2020	Precedex	dexmedetomidine HCl	Hospira	Mylan
08/28/2020	Cormax	clobetasol propionate	Akorn	Encube
08/31/2020	Namenda	memantine HCl	Allergan	Saptalis Pharms
08/31/2020	Cubicin	daptomycin	Cubist	Dr Reddys
08/31/2020	Thorazine	chlorpromazine HCl	Glaxo	Mayne Pharma
09/01/2020	Welchol	colesevelam HCl	Genzyme	Watson
09/01/2020	Fentanyl Citrate	fentanyl citrate	Hospira	Fresenius Kabi
09/01/2020	Sporanox	itraconazole	Janssen	Annora Pharma
09/01/2020	Proamatine	midodrine HCl	Takeda	Zydus
09/01/2020	Nimbex	cisatracurium besylate	AbbVie	Zydus
09/02/2020	Welchol	colesevelam HCl	Daiichi Sankyo	Watson
09/02/2020	Meticorten	prednisone	Schering	Strides
09/02/2020	Firazyr	icatibant acetate	Shire	Slayback Pharma
09/02/2020	Taclonex	calcipotriene / betamethasone dipropionate	LEO Pharma	Taro
09/03/2020	Primacor	milrinone lactate in dextrose 5%	Sanofi Aventis	Aurobindo
09/04/2020	Singulair	montelukast sodium	Merck	Amneal Pharms
09/04/2020	Sinequan	doxepin HCl	Pfizer	Upsher Smith
09/08/2020	Lumigan	bimatoprost	Allergan	Micro Labs
09/08/2020	Emend I.V.	fosaprepitant dimeglumine	Merck	Qilu
09/09/2020	Potassium Chloride	potassium chloride	Baxter	Fresenius Kabi
09/09/2020	Ammonia N 13	ammonia N 13	Feinstein Institute	Univ Wisconsin
09/09/2020	Nascobal	cyanocobalamin	Endo	Perrigo
09/09/2020	Lotronex	alosetron HCl	Sebela	Mankind Pharma
09/09/2020	Focalin XR	dexmethylphenidate HCl	Novartis	Granules Pharms
09/10/2020	Nexavar	sorafenib tosylate	Bayer	Mylan
09/10/2020	Doxil (Liposomal)	doxorubicin HCl	Baxter	Zydus
09/10/2020	Dextrose 5% and Potassium Chloride 0.075%	dextrose 5% and potassium chloride 0.075%	Baxter	Fresenius Kabi
09/10/2020	Dextrose 5% and Potassium Chloride 0.15%	dextrose 5% and potassium chloride 0.15%	Baxter	Fresenius Kabi
09/10/2020	Accolate	zafirlukast	Par	Annora Pharma
09/10/2020	Claritin	loratadine	Glaxo	Rubicon
09/11/2020	Vascepa	icosapent ethyl	Amarin	Teva
09/11/2020	Eliquis	apixaban	Bristol-Myers Squibb	Indoco
09/11/2020	Timoptic in Ocudose	timolol maleate	Bausch & Lomb	Akorn
09/11/2020	Taclonex	calcipotriene / bethamethasone dipropionate	LEO Pharma	Perrigo
09/11/2020	Zyrtec Allergy	cetirizine HCl	Johnson & Johnson	Aurobindo
09/14/2020	Dextrose 5% and Sodium Chloride 0.9%	dextrose 5% and sodium chloride 0.9%	ICU Medical	Fresenius Kabi
09/14/2020	Parafone Forte	chlorzoxazone	Mikart	I3 Pharms
09/14/2020	Zovirax	acyclovir	Mylan	Yiling
09/15/2020	Hectorol	doxercalciferol	Genzyme	Avet
09/15/2020	Precedex	dexmedetomidine HCl	Hospira	Par
09/15/2020	Dextrose 5% and Sodium Chloride 0.225%	dextrose 5% and sodium chloride 0.225%	ICU Medical	Fresenius Kabi
09/15/2020	Dextrose 5% and Sodium Chloride 0.45%	dextrose 5% and sodium chloride 0.45%	ICU Medical	Fresenius Kabi
09/15/2020	Zestril	lisinopril	Alvogen	Yiling
09/16/2020	Diprivan	propofol	Fesenius Kabi	Innopharma
09/16/2020	Tambocor	flecainide acetate	County Line	Beximco Pharms
09/17/2020	Uceris	budesonide	Bausch & Lomb	Mylan
09/17/2020	DDAVP	desmopressin acetate	Ferring	UBI
09/17/2020	K-Dur	potassium chloride	Upsher-Smith	Zydus Pharms
09/17/2020	Erythrocin	erythromycin lactobionate	Hospira	Exela Pharma
09/17/2020	Potassium Chloride 0.15% in Sodium Chloride 0.45%	potassium chloride 0.15% in sodium chloride 0.45%	Baxter	Fresenius Kabi
09/17/2020	Potassium Chloride 0.3% and Sodium Chloride 0.9%	potassium chloride 0.3% and sodium chloride 0.9%	Baxter	Fresenius Kabi
09/18/2020	Sensipar	cinacalcet HCl	Amgen	Dr Reddys
09/18/2020	Ponstel	mefenamic acid	Avion	Strides
09/18/2020	Claritin RediTabs	loratadine	Bayer	Tenshi
09/21/2020	butalbital / acetaminophen / caffeine	butalbital / acetaminophen / caffeine	Vintage	Strides
09/21/2020	Cetirizine HCl Allergy	cetirizine HCl allergy	Bionpharma	Catalent
09/21/2020	Emla	lidocaine / prilocaine	Teva	Rhodes Pharms
09/21/2020	Imitrex	sumatriptan	Glaxo	Perrigo
09/21/2020	Isopto Carpine	pilocarpine HCl	Novartis	Amneal
09/22/2020	Naftin	naftifine HCl	Sebela	Genzum
09/22/2020	Nexium	esomeprazole magnesium	AstraZeneca	Cisen
09/23/2020	Exalgo	hydromorphone HCl	SpecGx	Ascent Pharms
09/24/2020	Alaway	Ketotifen Fumarate	Bausch	Bausch
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	Cipla
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	Amneal
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	Alkem Labs
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	MSN
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	Accord Healthcare
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	Hetero Labs
09/24/2020	Tecfidera	dimethyl fumarate	Biogen	Zydus Pharms
09/24/2020	Aleve PM	naproxen sodium / diphenhydramine HCl	Bayer	Granules
09/24/2020	Rubramin PC	cyanocobalamin	Bristol-Myers Squibb	Gland Pharma
09/29/2020	Tykerb	lapatinib ditosylate	Novartis	Natco Pharma
09/29/2020	Atropine Sulfate	atropine sulfate	Accord	Accord Healthcare
09/30/2020	Bromfed DM	brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide	Wockhardt	Breckenridge
09/30/2020	Trandate	labetalol HCl	County Line	Epic Pharma

GENERICally Speaking Fall 2020

Oren D. Langer

Partner

Managing Partner, New York Office

Jeffrey Alan Hovden

Partner

Christopher A. Pinahs

Partner

GENERICally Speaking Fall 2020

VOL. 10, NO. 3

First Quarter

ANDA Litigation Settlements