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FDA drug approvals in 2015

FDA approved the original submission of 117 new drug and biologics license applications in 2015, from 85 sponsors. FDA marks 21 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 28, 2015	ZOLEDRONIC ACID	zoledronic acid	HOSPIRA	NDA204016
December 25, 2015	MEDICAL AIR, USP	medical air	CENTRAL WELDING SUPPLY	NDA208835
December 22, 2015	DOCETAXEL	docetaxel	SHILPA	NDA205934
December 22, 2015	ZURAMPIC	lesinurad	IRONWOOD PHARMS INC	NDA207988
December 21, 2015	UPTRAVI	selexipag	ACTELION	NDA207947
December 17, 2015	EMEND	aprepitant	MSD MERCK CO	NDA207865
December 16, 2015	BASAGLAR	insulin glargine	ELI LILLY AND CO	BLA205692
December 15, 2015	BRIDION	sugammadex sodium	MSD SUB MERCK	NDA022225
December 11, 2015	ALECENSA	alectinib hydrochloride	HOFFMANN-LA ROCHE	NDA208434
December 11, 2015	VISTOGARD	uridine triacetate	BTG INTL	NDA208159
December 10, 2015	OTIPRIO	ciprofloxacin	ALK ABELLO	NDA207986
December 8, 2015	KANUMA	sebelipase alfa	ALEXION PHARM	BLA125561
December 7, 2015	BENDEKA	bendamustine hydrochloride	EAGLE PHARMS	NDA208194
December 4, 2015	QUILLICHEW ER	methylphenidate hydrochloride	NEXTWAVE PHARMS	NDA207960
November 30, 2015	EMPLICITI	elotuzumab	BRISTOL MYERS SQUIBB	BLA761035
November 24, 2015	PORTRAZZA	necitumumab	ELI LILLY CO	BLA125547
November 23, 2015	NEXIUM 24HR	esomeprazole magnesium	ASTRAZENECA LP	NDA207920
November 20, 2015	NINLARO	ixazomib citrate	TAKEDA PHARMS USA	NDA208462
November 18, 2015	NARCAN	naloxone hydrochloride	EMERGENT	NDA208411
November 16, 2015	DARZALEX	daratumumab	JANSSEN BIOTECH	BLA761036
November 13, 2015	TAGRISSO	osimertinib mesylate	ASTRAZENECA	NDA208065
November 10, 2015	COTELLIC	cobimetinib fumarate	GENENTECH INC	NDA206192
November 6, 2015	ULTRAVATE	halobetasol propionate	LACER PHARMA	NDA208183
November 5, 2015	GENVOYA	cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate	GILEAD SCIENCES INC	NDA207561
November 4, 2015	NUCALA	mepolizumab	GLAXOSMITHKLINE LLC	BLA125526
October 29, 2015	SEEBRI NEOHALER	glycopyrrolate	NOVARTIS	NDA207923
October 29, 2015	UTIBRON NEOHALER	glycopyrrolate, indacaterol maleate	NOVARTIS	NDA207930
October 28, 2015	ACETAMINOPHEN	acetaminophen	FRESENIUS KABI USA	NDA204767
October 23, 2015	BELBUCA	buprenorphine hydrochloride	BDSI	NDA207932
October 23, 2015	STRENSIQ	asfotase alfa	ALEXION PHARM	BLA125513
October 23, 2015	YONDELIS	trabectedin	JANSSEN PRODS	NDA207953
October 22, 2015	ONIVYDE	irinotecan hydrochloride	IPSEN	NDA207793
October 22, 2015	VIVLODEX	meloxicam	ICEUTICA OPERATIONS	NDA207233
October 21, 2015	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	HQ SPCLT PHARMA	NDA206628
October 21, 2015	VELTASSA	patiromer sorbitex calcium	VIFOR PHARMA	NDA205739
October 19, 2015	DYANAVEL XR	amphetamine, amphetamine aspartate/dextroamphetamine sulfate	TRIS PHARMA INC	NDA208147
October 16, 2015	ENSTILAR	betamethasone dipropionate, calcipotriene	LEO PHARMA AS	NDA207589
October 16, 2015	PRAXBIND	idarucizumab	BOEHRINGER INGELHEIM	BLA761025
October 5, 2015	ARISTADA	aripiprazole lauroxil	ALKERMES INC	NDA207533
October 2, 2015	MORPHABOND ER	morphine sulfate	OHEMO LIFE	NDA206544
September 25, 2015	RYZODEG 70/30	insulin aspart, insulin degludec	NOVO	BLA203313
September 25, 2015	TRESIBA	insulin degludec	NOVO	BLA203314
September 22, 2015	LONSURF	tipiracil hydrochloride, trifluridine	TAIHO ONCOLOGY	NDA207981
September 18, 2015	TOLAK	fluorouracil	HILL DERMACEUTICALS	NDA022259
September 17, 2015	VRAYLAR	cariprazine hydrochloride	ABBVIE	NDA204370
September 15, 2015	SPIRIVA RESPIMAT	tiotropium bromide	BOEHRINGER INGELHEIM	NDA207070
September 9, 2015	FERRIPROX	deferiprone	CHIESI	NDA208030
September 4, 2015	DURLAZA	aspirin	HESP	NDA200671
September 4, 2015	XURIDEN	uridine triacetate	BTG INTL	NDA208169
September 1, 2015	VARUBI	rolapitant hydrochloride	TERSERA	NDA206500
August 27, 2015	REPATHA	evolocumab	AMGEN INC	BLA125522
August 26, 2015	SYNJARDY	empagliflozin, metformin hydrochloride	BOEHRINGER INGELHEIM	NDA206111
August 24, 2015	PROMACTA KIT	eltrombopag olamine	NOVARTIS	NDA207027
August 19, 2015	POKONZA	potassium chloride	GENUS	NDA208019
August 18, 2015	ADDYI	flibanserin	SPROUT PHARMS	NDA022526
August 7, 2015	CEFAZOLIN IN DEXTROSE	cefazolin sodium	BAXTER HLTHCARE CORP	NDA207131
July 31, 2015	SPRITAM	levetiracetam	APRECIA PHARMS	NDA207958
July 29, 2015	FINACEA	azelaic acid	LEO PHARMA AS	NDA207071
July 24, 2015	DAKLINZA	daclatasvir dihydrochloride	BRISTOL-MYERS SQUIBB	NDA206843
July 24, 2015	ODOMZO	sonidegib phosphate	SUN PHARM	NDA205266
July 24, 2015	PRALUENT	alirocumab	REGENERON PHARMACEUTICALS	BLA125559
July 24, 2015	TECHNIVIE	ombitasvir, paritaprevir, ritonavir	ABBVIE	NDA207931
July 15, 2015	EPIDUO FORTE	adapalene, benzoyl peroxide	GALDERMA LABS	NDA207917
July 13, 2015	IRESSA	gefitinib	ASTRAZENECA	NDA206995
July 10, 2015	ENVARSUS XR	tacrolimus	VELOXIS PHARMS INC	NDA206406
July 10, 2015	REXULTI	brexpiprazole	OTSUKA	NDA205422
July 7, 2015	ENTRESTO	sacubitril, valsartan	NOVARTIS PHARMS CORP	NDA207620
July 2, 2015	ORKAMBI	ivacaftor, lumacaftor	VERTEX PHARMS INC	NDA206038
June 22, 2015	KENGREAL	cangrelor	CHIESI	NDA204958
June 22, 2015	TUXARIN ER	chlorpheniramine maleate, codeine phosphate	MAINPOINTE	NDA206323
June 18, 2015	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	linezolid	HOSPIRA	NDA206473
June 1, 2015	METAXALONE	metaxalone	PRIMUS PHARMS	NDA022503
May 27, 2015	VIBERZI	eluxadoline	ABBVIE	NDA206940
May 26, 2015	HUMALOG KWIKPEN	insulin lispro recombinant	ELI LILLY AND CO	BLA205747
May 21, 2015	STIOLTO RESPIMAT	olodaterol hydrochloride, tiotropium bromide	BOEHRINGER INGELHEIM	NDA206756
May 18, 2015	INVEGA HAFYERA	paliperidone palmitate	JANSSEN PHARMS	NDA207946
May 14, 2015	FLOWTUSS	guaifenesin, hydrocodone bitartrate	CHARTWELL RX	NDA022424
May 14, 2015	HYCOFENIX	guaifenesin, hydrocodone bitartrate, pseudoephedrine hydrochloride	CHARTWELL RX	NDA022279
May 8, 2015	GLUCAGON	glucagon hydrochloride	FRESENIUS KABI USA	NDA201849
April 30, 2015	MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	meropenem	B BRAUN MEDICAL	NDA202106
April 30, 2015	TUZISTRA XR	chlorpheniramine polistirex, codeine polistirex	TRIS PHARMA INC	NDA207768
April 29, 2015	KYBELLA	deoxycholic acid	ABBVIE	NDA206333
April 17, 2015	APTENSIO XR	methylphenidate hydrochloride	RHODES PHARMS	NDA205831
April 15, 2015	CORLANOR	ivabradine hydrochloride	AMGEN INC	NDA206143
April 3, 2015	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	FRESENIUS KABI USA	NDA205572
March 31, 2015	PROAIR RESPICLICK	albuterol sulfate	TEVA BRANDED PHARM	NDA205636
March 30, 2015	JADENU	deferasirox	NOVARTIS PHARMS CORP	NDA206910
March 26, 2015	ORALTAG	iohexol	INTERPHARMA PRAHA AS	NDA205383
March 23, 2015	ARGATROBAN	argatroban	FRESENIUS KABI USA	NDA201811
March 17, 2015	CHOLBAM	cholic acid	MIRUM	NDA205750
March 17, 2015	KALYDECO	ivacaftor	VERTEX PHARMS INC	NDA207925
March 10, 2015	UNITUXIN	dinutuximab	UNITED THERAP	BLA125516
March 6, 2015	CRESEMBA	isavuconazonium sulfate	ASTELLAS	NDA207500
March 6, 2015	CRESEMBA	isavuconazonium sulfate	ASTELLAS	NDA207501
March 6, 2015	ZARXIO	filgrastim-sndz	SANDOZ INC	BLA125553
March 4, 2015	OPDIVO	nivolumab	BRISTOL MYERS SQUIBB	BLA125527
February 26, 2015	LILETTA	levonorgestrel	MEDICINES360	NDA206229
February 25, 2015	AVYCAZ	avibactam sodium, ceftazidime	ABBVIE	NDA206494
February 25, 2015	TOUJEO SOLOSTAR	insulin glargine recombinant	SANOFI US SERVICES	BLA206538
February 23, 2015	FARYDAK	panobinostat lactate	SECURA	NDA205353
February 13, 2015	LENVIMA	lenvatinib mesylate	EISAI INC	NDA206947
February 6, 2015	DUTREBIS	lamivudine, raltegravir potassium	MERCK SHARP DOHME	NDA206510
February 3, 2015	IBRANCE	palbociclib	PFIZER	NDA207103
January 30, 2015	GLYXAMBI	empagliflozin, linagliptin	BOEHRINGER INGELHEIM	NDA206073
January 30, 2015	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	ALCON LABS INC	NDA206276
January 29, 2015	EVOTAZ	atazanavir sulfate, cobicistat	BRISTOL	NDA206353
January 29, 2015	PREZCOBIX	cobicistat, darunavir ethanolate	JANSSEN PRODS	NDA205395
January 23, 2015	NATPARA	parathyroid hormone	NPS PHARMS INC	BLA125511
January 23, 2015	TRIFERIC	ferric pyrophosphate citrate	ROCKWELL MEDICAL INC	NDA206317
January 21, 2015	COSENTYX	secukinumab	NOVARTIS PHARMS CORP	BLA125504
January 21, 2015	PRESTALIA	amlodipine besylate, perindopril arginine	ADHERA	NDA205003
January 15, 2015	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	ALCON	NDA207926
January 13, 2015	PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER	calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate	VANTIVE US HLTHCARE	NDA207026
January 9, 2015	DUOPA	carbidopa, levodopa	ABBVIE	NDA203952
January 8, 2015	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	FRESENIUS KABI USA	NDA203629
January 8, 2015	SAVAYSA	edoxaban tosylate	DAIICHI SANKYO INC	NDA206316
January 7, 2015	RYTARY	carbidopa, levodopa	IMPAX	NDA203312