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FDA drug approvals in 2014

FDA approved the original submission of 110 new drug and biologics license applications in 2014, from 88 sponsors. FDA marks 27 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 23, 2014	DYLOJECT	diclofenac sodium	JAVELIN PHARMS INC	NDA022396
December 23, 2014	NAMZARIC	donepezil hydrochloride, memantine hydrochloride	ABBVIE	NDA206439
December 23, 2014	SAXENDA	liraglutide	NOVO	NDA206321
December 22, 2014	OPDIVO	nivolumab	BRISTOL MYERS SQUIBB	BLA125554
December 22, 2014	POKONZA	potassium chloride	GENUS LIFESCIENCES	NDA206814
December 19, 2014	LYNPARZA	olaparib	ASTRAZENECA	NDA206162
December 19, 2014	RAPIVAB	peramivir	BIOCRYST	NDA206426
December 19, 2014	SOOLANTRA	ivermectin	GALDERMA LABS LP	NDA206255
December 19, 2014	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium, ombitasvir, paritaprevir, ritonavir	ABBVIE	NDA206619
December 19, 2014	ZERBAXA	ceftolozane sulfate, tazobactam sodium	CUBIST PHARMS LLC	NDA206829
December 17, 2014	XTORO	finafloxacin	FONSECA BIOSCIENCES	NDA206307
December 15, 2014	ARGATROBAN IN 0.9% SODIUM CHLORIDE	argatroban	TEVA PHARMS USA	NDA206769
December 15, 2014	SIGNIFOR LAR KIT	pasireotide pamoate	RECORDATI RARE	NDA203255
December 3, 2014	BLINCYTO	blinatumomab	AMGEN	BLA125557
December 2, 2014	KITABIS PAK	tobramycin	PULMOFLOW INC	NDA205433
November 25, 2014	NITROUS OXIDE, USP	nitrous oxide	STRATA MEDICAL INNOVATIONS	NDA208069
November 18, 2014	PARICALCITOL	paricalcitol	HIKMA PHARMS	NDA205917
November 14, 2014	OBREDON	guaifenesin, hydrocodone bitartrate	SOVEREIGN PHARMS	NDA205474
October 29, 2014	XIGDUO XR	dapagliflozin, metformin hydrochloride	ASTRAZENECA AB	NDA205649
October 22, 2014	SOTYLIZE	sotalol hydrochloride	AZURITY	NDA205108
October 21, 2014	PARICALCITOL	paricalcitol	HOSPIRA	NDA201657
October 15, 2014	ESBRIET	pirfenidone	LEGACY	NDA022535
October 15, 2014	OFEV	nintedanib esylate	BOEHRINGER INGELHEIM	NDA205832
October 10, 2014	AKYNZEO	netupitant, palonosetron hydrochloride	HELSINN HLTHCARE	NDA205718
October 10, 2014	HARVONI	ledipasvir, sofosbuvir	GILEAD SCIENCES INC	NDA205834
October 10, 2014	LUMASON	sulfur hexafluoride lipid-type a microspheres	BRACCO	NDA203684
October 7, 2014	UCERIS	budesonide	SALIX	NDA205613
September 26, 2014	ILUVIEN	fluocinolone acetonide	ALIMERA SCIENCES INC	NDA201923
September 26, 2014	MITIGARE	colchicine	HIKMA INTL PHARMS	NDA204820
September 24, 2014	FOSRENOL	lanthanum carbonate	TAKEDA PHARMS USA	NDA204734
September 24, 2014	SPIRIVA RESPIMAT	tiotropium bromide	BOEHRINGER INGELHEIM	NDA021936
September 24, 2014	TYBOST	cobicistat	GILEAD SCIENCES INC	NDA203094
September 24, 2014	VITEKTA	elvitegravir	GILEAD SCIENCES INC	NDA203093
September 23, 2014	OTEZLA	apremilast	CELGENE CORP	NDA206088
September 18, 2014	TRULICITY	dulaglutide	ELI LILLY AND CO	BLA125469
September 16, 2014	MOVANTIK	naloxegol oxalate	AVERITAS	NDA204760
September 10, 2014	CONTRAVE	bupropion hydrochloride, naltrexone hydrochloride	AZURITY	NDA200063
September 5, 2014	AURYXIA	ferric citrate	KERYX BIOPHARMS	NDA205874
September 4, 2014	KEYTRUDA	pembrolizumab	MERCK SHARP DOHME	BLA125514
August 25, 2014	KABIVEN IN PLASTIC CONTAINER	amino acids, calcium chloride, dextrose, magnesium sulfate, potassium chloride, sodium acetate, sodium glycerophosphate, soybean oil	FRESENIUS KABI USA	NDA200656
August 22, 2014	TRIUMEQ	abacavir sulfate, dolutegravir sodium, lamivudine	VIIV HLTHCARE	NDA205551
August 20, 2014	ARNUITY ELLIPTA	fluticasone furoate	GLAXOSMITHKLINE	NDA205625
August 19, 2014	CERDELGA	eliglustat tartrate	GENZYME CORP	NDA205494
August 15, 2014	PLEGRIDY	peginterferon beta-1a	BIOGEN IDEC INC	BLA125499
August 13, 2014	BELSOMRA	suvorexant	MERCK SHARP DOHME	NDA204569
August 8, 2014	INVOKAMET	canagliflozin, metformin hydrochloride	JANSSEN PHARMS	NDA204353
August 6, 2014	ORBACTIV	oritavancin diphosphate	MELINTA THERAP	NDA206334
August 1, 2014	JARDIANCE	empagliflozin	BOEHRINGER INGELHEIM	NDA204629
July 31, 2014	STRIVERDI RESPIMAT	olodaterol hydrochloride	BOEHRINGER INGELHEIM	NDA203108
July 29, 2014	EPINEPHRINE	epinephrine	BPI LABS	NDA205029
July 25, 2014	ACTICLATE	doxycycline hyclate	CHARTWELL RX	NDA205931
July 23, 2014	FLONASE ALLERGY RELIEF	fluticasone propionate	HALEON US HOLDINGS	NDA205434
July 23, 2014	TARGINIQ	naloxone hydrochloride, oxycodone hydrochloride	PURDUE PHARMA LP	NDA205777
July 23, 2014	ZYDELIG	idelalisib	GILEAD SCIENCES INC	NDA205858
July 23, 2014	ZYDELIG	idelalisib	GILEAD SCIENCES INC	NDA206545
July 22, 2014	RYANODEX	dantrolene sodium	EAGLE PHARMS	NDA205579
July 18, 2014	ATROPINE SULFATE	atropine sulfate	RISING	NDA206289
July 10, 2014	RASUVO	methotrexate	MEDEXUS	NDA205776
July 7, 2014	KERYDIN	tavaborole	ANACOR PHARMS INC	NDA204427
July 3, 2014	BELEODAQ	belinostat	ACROTECH BIOPHARMA	NDA206256
June 27, 2014	AFREZZA	insulin recombinant human	MANNKIND	BLA022472
June 27, 2014	VAZCULEP	phenylephrine hydrochloride	EXELA PHARMA	NDA204300
June 20, 2014	SIVEXTRO	tedizolid phosphate	CUBIST PHARMS LLC	NDA205435
June 20, 2014	SIVEXTRO	tedizolid phosphate	CUBIST PHARMS LLC	NDA205436
June 6, 2014	BUNAVAIL	buprenorphine hydrochloride, naloxone hydrochloride	BDSI	NDA205637
June 6, 2014	JUBLIA	efinaconazole	BAUSCH	NDA203567
June 4, 2014	VOGELXO	testosterone	UPSHER SMITH LABS	NDA204399
June 2, 2014	REYATAZ	atazanavir sulfate	BRISTOL MYERS SQUIBB	NDA206352
May 30, 2014	OMIDRIA	ketorolac tromethamine, phenylephrine hydrochloride	RAYNER SURGICAL	NDA205388
May 28, 2014	NATESTO	testosterone	ACERUS	NDA205488
May 25, 2014	CARBON DIOXIDE, USP	carbon dioxide	RELIANT HOLDINGS LTD	NDA207166
May 23, 2014	DALVANCE	dalbavancin hydrochloride	ABBVIE	NDA021883
May 20, 2014	ENTYVIO	vedolizumab	TAKEDA PHARMS USA	BLA125476
May 15, 2014	IZBA	travoprost	NOVARTIS	NDA204822
May 12, 2014	MEDICAL AIR, USP	medical air	AMERICAN WELDING AND GAS INC	NDA207114
May 8, 2014	ZONTIVITY	vorapaxar sulfate	KEY THERAP	NDA204886
May 5, 2014	EPANOVA	omega-3-carboxylic acids	ASTRAZENECA	NDA205060
April 30, 2014	INCRUSE ELLIPTA	umeclidinium bromide	GLAXO GRP ENGLAND	NDA205382
April 29, 2014	ZYKADIA	ceritinib	NOVARTIS	NDA205755
April 28, 2014	PURIXAN	mercaptopurine	NOVA LABS LTD	NDA205919
April 25, 2014	ASMANEX HFA	mometasone furoate	ORGANON LLC	NDA205641
April 23, 2014	OMTRYG	omega-3-acid ethyl esters type a	OSMOTICA PHARM US	NDA204977
April 23, 2014	SYLVANT	siltuximab	RECORDATI RARE DISEASES, INC.	BLA125496
April 22, 2014	MEDICAL AIR, USP	medical air	CEE KAY SUPPLY	NDA207036
April 21, 2014	CYRAMZA	ramucirumab	ELI LILLY AND CO	BLA125477
April 17, 2014	VASOSTRICT	vasopressin	PH HEALTH	NDA204485
April 15, 2014	TANZEUM	albiglutide	GLAXOSMITHKLINE LLC	BLA125431
April 3, 2014	EVZIO	naloxone hydrochloride	KALEO INC	NDA205787
March 28, 2014	NEXIUM 24HR	esomeprazole magnesium	ASTRAZENECA LP	NDA204655
March 24, 2014	NUVESSA	metronidazole	ALEMBIC THERAP	NDA205223
March 21, 2014	OTEZLA	apremilast	AMGEN INC	NDA205437
March 19, 2014	IMPAVIDO	miltefosine	KNIGHT THERAPS	NDA204684
March 19, 2014	NEURACEQ	florbetaben f-18	LANTHEUS	NDA204677
March 14, 2014	HEMANGEOL	propranolol hydrochloride	ETON	NDA205410
March 13, 2014	DOCETAXEL	docetaxel	PFIZER LABS	NDA202356
March 13, 2014	NOXAFIL	posaconazole	MERCK SHARP DOHME	NDA205596
March 11, 2014	QUDEXY XR	topiramate	UPSHER SMITH LABS	NDA205122
March 11, 2014	XARTEMIS XR	acetaminophen, oxycodone hydrochloride	MALLINCKRODT INC	NDA204031
March 5, 2014	AVEED	testosterone undecanoate	ENDO OPERATIONS	NDA022219
March 4, 2014	HELIUM, USP	helium	LINDE GAS NORTH AMERICA LLC	NDA206826
February 24, 2014	MYALEPT	metreleptin	CHIESI FARMACEUTICI SPA	BLA125390
February 24, 2014	TIVORBEX	indomethacin	GENUS	NDA204768
February 18, 2014	NORTHERA	droxidopa	LUNDBECK NA LTD	NDA203202
February 14, 2014	VIMIZIM	elosulfase alfa	BIOMARIN PHARM	BLA125460
January 31, 2014	HETLIOZ	tasimelteon	VANDA PHARMS INC	NDA205677
January 28, 2014	DESVENLAFAXINE	desvenlafaxine fumarate	SUN PHARM	NDA205583
January 23, 2014	DECITABINE	decitabine	SUN PHARM	NDA205582
January 17, 2014	ALEVE PM	diphenhydramine hydrochloride, naproxen sodium	BAYER HLTHCARE	NDA205352
January 16, 2014	PENNSAID	diclofenac sodium	HORIZON	NDA204623
January 8, 2014	FARXIGA	dapagliflozin	ASTRAZENECA AB	NDA202293