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FDA drug approvals in 2010

FDA approved the original submission of 85 new drug and biologics license applications in 2010, from 66 sponsors. FDA marks 18 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 29, 2010	FORTESTA	testosterone	ENDO OPERATIONS	NDA021463
December 22, 2010	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol, norethindrone	TEVA BRANDED PHARM	NDA022573
December 21, 2010	AMTURNIDE	aliskiren hemifumarate, amlodipine besylate, hydrochlorothiazide	NOVARTIS	NDA200045
December 16, 2010	SAFYRAL	drospirenone, ethinyl estradiol, levomefolate calcium	BAYER HLTHCARE	NDA022574
November 23, 2010	AXIRON	testosterone	ELI LILLY AND CO	NDA022504
November 19, 2010	GABLOFEN	baclofen	PIRAMAL CRITICAL	NDA022462
November 19, 2010	MOXEZA	moxifloxacin hydrochloride	HARROW EYE	NDA022428
November 15, 2010	HALAVEN	eribulin mesylate	EISAI INC	NDA201532
November 10, 2010	EGRIFTA	tesamorelin acetate	THERATECHNOLOGIES	BLA022505
November 5, 2010	KOMBIGLYZE XR	metformin hydrochloride, saxagliptin hydrochloride	ASTRAZENECA AB	NDA200678
November 4, 2010	CYMBALTA	duloxetine hydrochloride	LILLY	NDA022516
November 2, 2010	OFIRMEV	acetaminophen	MALLINCKRODT HOSP	NDA022450
October 29, 2010	NUEDEXTA	dextromethorphan hydrobromide, quinidine sulfate	OTSUKA AMERICA PHARM	NDA021879
October 29, 2010	TEFLARO	ceftaroline fosamil	ABBVIE	NDA200327
October 28, 2010	LATUDA	lurasidone hydrochloride	SUNOVION PHARMS INC	NDA200603
October 21, 2010	LO LOESTRIN FE	ethinyl estradiol, norethindrone acetate	APIL	NDA022501
October 20, 2010	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	GENUS LIFESCIENCES	NDA200534
October 20, 2010	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	GENUS LIFESCIENCES	NDA200535
October 19, 2010	PRADAXA	dabigatran etexilate mesylate	BOEHRINGER INGELHEIM	NDA022512
October 15, 2010	H.P. ACTHAR GEL	repository corticotropin	QUESTCOR PHARMA	NDA022432
October 8, 2010	ATELVIA	risedronate sodium	APIL	NDA022560
October 6, 2010	SORILUX	calcipotriene	MAYNE PHARMA	NDA022563
October 5, 2010	ARIDOL KIT	mannitol	PHARMAXIS EUROPE	NDA022368
September 24, 2010	BEYAZ	drospirenone, ethinyl estradiol, levomefolate calcium	BAYER HLTHCARE	NDA022532
September 21, 2010	GILENYA	fingolimod hydrochloride	NOVARTIS	NDA022527
September 14, 2010	KRYSTEXXA	pegloticase	HORIZON PHARMA	BLA125293
September 3, 2010	ZYRTEC ALLERGY	cetirizine hydrochloride	KENVUE BRANDS	NDA022578
August 31, 2010	LUMIGAN	bimatoprost	ABBVIE	NDA022184
August 30, 2010	SUBOXONE	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR	NDA022410
August 26, 2010	TEKAMLO	aliskiren hemifumarate, amlodipine besylate	NOVARTIS	NDA022545
August 13, 2010	ELLA	ulipristal acetate	LAB HRA PHARMA	NDA022474
August 5, 2010	SUPREP BOWEL PREP KIT	magnesium sulfate, potassium sulfate, sodium sulfate	AZURITY	NDA022372
July 30, 2010	Xeomin	incobotulinumtoxina	MERZ PHARMS	BLA125360
July 28, 2010	CUVPOSA	glycopyrrolate	MERZ PHARMS	NDA022571
July 28, 2010	LASTACAFT	alcaftadine	ABBVIE	NDA022134
July 23, 2010	ARICEPT	donepezil hydrochloride	EISAI INC	NDA022568
July 23, 2010	TRIBENZOR	amlodipine besylate, hydrochlorothiazide, olmesartan medoxomil	COSETTE	NDA200175
July 16, 2010	VELTIN	clindamycin phosphate, tretinoin	CHARTWELL RX	NDA050803
July 2, 2010	ZUPLENZ	ondansetron	AQUESTIVE	NDA022524
June 30, 2010	BUTRANS	buprenorphine	KNOA PHARMA	NDA021306
June 29, 2010	ALSUMA	sumatriptan succinate	MERIDIAN MEDCL	NDA022377
June 22, 2010	DULERA	formoterol fumarate, mometasone furoate	ORGANON LLC	NDA022518
June 22, 2010	ISOPTO CARPINE	pilocarpine hydrochloride	SANDOZ	NDA200890
June 21, 2010	NAMENDA XR	memantine hydrochloride	ABBVIE	NDA022525
June 17, 2010	JEVTANA KIT	cabazitaxel	SANOFI AVENTIS US	NDA201023
June 17, 2010	STAXYN	vardenafil hydrochloride	BAYER HLTHCARE	NDA200179
June 14, 2010	JALYN	dutasteride, tamsulosin hydrochloride	WAYLIS THERAP	NDA022460
June 1, 2010	PROLIA	denosumab	AMGEN	BLA125320
May 28, 2010	CYSVIEW KIT	hexaminolevulinate hydrochloride	PHOTOCURE ASA	NDA022555
May 27, 2010	ADVIL CONGESTION RELIEF	ibuprofen, phenylephrine hydrochloride	HALEON US HOLDINGS	NDA022565
May 24, 2010	LUMIZYME	alglucosidase alfa	GENZYME	BLA125291
May 18, 2010	ZYMAXID	gatifloxacin	ABBVIE	NDA022548
May 14, 2010	SPRIX	ketorolac tromethamine	COSETTE	NDA022382
May 7, 2010	CONZIP	tramadol hydrochloride	CIPHER PHARMS INC	NDA022370
May 6, 2010	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	cefepime hydrochloride	B BRAUN	NDA050821
May 6, 2010	NATAZIA	dienogest, estradiol valerate	BAYER HLTHCARE	NDA022252
April 30, 2010	VIMOVO	esomeprazole magnesium, naproxen	HORIZON	NDA022511
April 29, 2010	ONMEL	itraconazole	SEBELA IRELAND LTD	NDA022484
April 20, 2010	VIMPAT	lacosamide	UCB INC	NDA022255
April 20, 2010	ZORTRESS	everolimus	NOVARTIS	NDA021560
April 16, 2010	ORAVIG	miconazole	GALT PHARMS	NDA022404
April 12, 2010	PANCREAZE	pancrelipase (amylase, lipase, protease)	VIVUS INC	BLA022523
April 5, 2010	OXYCONTIN	oxycodone hydrochloride	KNOA PHARMA	NDA022272
March 30, 2010	ASCLERA	polidocanol	CHEMISCH FBRK KRSSLR	NDA021201
March 25, 2010	ZYCLARA	imiquimod	BAUSCH	NDA022483
March 24, 2010	XIFAXAN	rifaximin	SALIX PHARMS	NDA022554
March 19, 2010	MIRAPEX ER	pramipexole dihydrochloride	BOEHRINGER INGELHEIM	NDA022514
March 18, 2010	CARBAGLU	carglumic acid	RECORDATI RARE	NDA022562
March 17, 2010	DIFFERIN	adapalene	GALDERMA LABS LP	NDA022502
March 17, 2010	INDOMETHACIN	indomethacin	FRESENIUS KABI USA	NDA022536
March 17, 2010	SILENOR	doxepin hydrochloride	CURRAX	NDA022036
March 10, 2010	TRELSTAR	triptorelin pamoate	VERITY	NDA022437
March 1, 2010	EXALGO	hydromorphone hydrochloride	SPECGX LLC	NDA021217
February 26, 2010	ORABLOC	articaine hydrochloride, epinephrine bitartrate	PIERREL	NDA022466
February 26, 2010	VPRIV	velaglucerase alfa	SHIRE HUMAN GENETIC	BLA022575
February 22, 2010	CAYSTON	aztreonam	GILEAD	NDA050814
February 19, 2010	MIRAPEX ER	pramipexole dihydrochloride	BOEHRINGER INGELHEIM	NDA022421
February 10, 2010	NORVIR	ritonavir	ABBVIE	NDA022417
February 2, 2010	OLEPTRO	trazodone hydrochloride	ANGELINI PHARMA	NDA022411
February 2, 2010	XIAFLEX	collagenase clostridium histolyticum	AUXILIUM PHARMS	BLA125338
January 29, 2010	LAMICTAL XR	lamotrigine	SMITHKLINE BEECHAM	NDA022509
January 25, 2010	VICTOZA	liraglutide	NOVO NORDISK INC	NDA022341
January 22, 2010	AMPYRA	dalfampridine	MERZ	NDA022250
January 8, 2010	ACTEMRA	tocilizumab	GENENTECH	BLA125276
January 4, 2010	LYRICA	pregabalin	UPJOHN	NDA022488