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FDA drug approvals in 2006

FDA approved the original submission of 103 new drug and biologics license applications in 2006, from 83 sponsors. FDA marks 28 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 29, 2006	ACTIVELLA	estradiol, norethindrone acetate	NOVO NORDISK INC	NDA022001
December 19, 2006	AZITHROMYCIN	azithromycin	TEVA PARENTERAL	NDA050809
December 19, 2006	INVEGA	paliperidone	JANSSEN PHARMS	NDA021999
December 15, 2006	CYANOKIT	hydroxocobalamin	BTG INTL	NDA022041
December 15, 2006	ELESTRIN	estradiol	VIATRIS	NDA021813
December 15, 2006	FORADIL CERTIHALER	formoterol fumarate	NOVARTIS	NDA021592
December 12, 2006	CLARITIN REDITABS	loratadine	BAYER HEALTHCARE LLC	NDA021993
December 1, 2006	CHILDREN'S ALAWAY	ketotifen fumarate	BAUSCH AND LOMB	NDA021996
November 7, 2006	ZIANA	clindamycin phosphate, tretinoin	BAUSCH	NDA050802
November 2, 2006	NITROMIST	nitroglycerin	EVUS	NDA021780
October 31, 2006	VEREGEN	sinecatechins	ANI PHARMS	NDA021902
October 25, 2006	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	calcium chloride, dextrose, lactic acid, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride	VANTIVE US HLTHCARE	NDA021703
October 25, 2006	TYZEKA	telbivudine	NOVARTIS	NDA022011
October 20, 2006	COREG CR	carvedilol phosphate	WAYLIS THERAP	NDA022012
October 20, 2006	DESONATE	desonide	LEO PHARMA AS	NDA021844
October 20, 2006	NEXIUM	esomeprazole magnesium	ASTRAZENECA	NDA021957
October 20, 2006	NOXAFIL	posaconazole	SCHERING	NDA022027
October 20, 2006	OMNARIS	ciclesonide	AZURITY	NDA022004
October 16, 2006	ALLEGRA	fexofenadine hydrochloride	CHATTEM SANOFI	NDA021963
October 16, 2006	JANUVIA	sitagliptin phosphate	MSD	NDA021995
October 13, 2006	TIROSINT	levothyroxine sodium	IBSA	NDA021924
October 6, 2006	BROVANA	arformoterol tartrate	LUPIN	NDA021912
October 6, 2006	MIRALAX	polyethylene glycol 3350	BAYER HEALTHCARE LLC	NDA022015
October 6, 2006	ZOLINZA	vorinostat	MSD SUB MERCK	NDA021991
October 5, 2006	ANTHELIOS 20	avobenzone, ecamsule, octocrylene, titanium dioxide	LOREAL USA	NDA021471
October 4, 2006	YAZ	drospirenone, ethinyl estradiol	BAYER HLTHCARE	NDA021873
October 2, 2006	CAPITAL SOLEIL 15	avobenzone, ecamsule, octocrylene	LOREAL USA	NDA021501
September 29, 2006	DURAPREP	iodine povacrylex, isopropyl alcohol	SOLVENTUM	NDA021586
September 28, 2006	DUODOTE	atropine, pralidoxime chloride	MMT	NDA021983
September 28, 2006	PYLERA	bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride	LABS JUVISE	NDA050786
September 27, 2006	VECTIBIX	panitumumab	AMGEN	BLA125147
September 25, 2006	FENTORA	fentanyl citrate	CEPHALON	NDA021947
September 21, 2006	TRAVATAN Z	travoprost	SANDOZ	NDA021994
September 20, 2006	ABILIFY	aripiprazole	OTSUKA	NDA021866
September 19, 2006	VERDESO	desonide	GENUS	NDA021978
September 15, 2006	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	HOSPIRA	NDA050807
September 15, 2006	NOXAFIL	posaconazole	SCHERING	NDA022003
August 28, 2006	DUTOPROL	hydrochlorothiazide, metoprolol succinate	CONCORDIA	NDA021956
August 23, 2006	CHILDREN'S CLARITIN	loratadine	BAYER HEALTHCARE LLC	NDA021891
August 2, 2006	MOVIPREP	ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, sodium sulfate	SALIX PHARMS	NDA021881
July 31, 2006	KEPPRA	levetiracetam	UCB INC	NDA021872
July 28, 2006	DUETACT	glimepiride, pioglitazone hydrochloride	TAKEDA PHARMS USA	NDA021925
July 28, 2006	XOLEGEL	ketoconazole	INA PHARMS	NDA021946
July 27, 2006	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	LIEBEL-FLARSHEIM	NDA021569
July 26, 2006	NORMOCARB HF 35	magnesium chloride, sodium bicarbonate, sodium chloride	DIALYSIS SUPS	NDA021910
July 24, 2006	ELAPRASE	idursulfase	SHIRE	BLA125151
July 24, 2006	LAMISIL AT	terbinafine	KARO HLTHCARE	NDA021958
July 21, 2006	ANTHELIOS SX	avobenzone, ecamsule, octocrylene	LOREAL USA	NDA021502
July 21, 2006	SYMBICORT	budesonide, formoterol fumarate dihydrate	ASTRAZENECA	NDA021929
July 17, 2006	IMPLANON	etonogestrel	ORGANON	NDA021529
July 12, 2006	ATRIPLA	efavirenz, emtricitabine, tenofovir disoproxil fumarate	GILEAD SCIENCES	NDA021937
July 12, 2006	PULMICORT FLEXHALER	budesonide	CHEPLAPHARM	NDA021949
June 30, 2006	LUCENTIS	ranibizumab	GENENTECH	BLA125156
June 29, 2006	PLIAGLIS	lidocaine, tetracaine	CRESCITA THERAP	NDA021717
June 28, 2006	SPRYCEL	dasatinib	BRISTOL MYERS SQUIBB	NDA021986
June 28, 2006	SPRYCEL	dasatinib	BRISTOL MYERS SQUIBB	NDA022072
June 23, 2006	PREZISTA	darunavir	JANSSEN PRODS	NDA021976
June 22, 2006	OPANA	oxymorphone hydrochloride	ENDO PHARMS	NDA021611
June 22, 2006	OPANA ER	oxymorphone hydrochloride	ENDO OPERATIONS	NDA021610
June 14, 2006	ZELAPAR	selegiline hydrochloride	BAUSCH	NDA021479
June 8, 2006	ADVAIR HFA	fluticasone propionate, salmeterol xinafoate	GLAXO GRP LTD	NDA021254
June 7, 2006	ABILIFY	aripiprazole	OTSUKA	NDA021729
June 1, 2006	ORAPRED ODT	prednisolone sodium phosphate	ADVANZ PHARMA	NDA021959
May 30, 2006	OMNITROPE	somatropin	SANDOZ	BLA021426
May 26, 2006	ORACEA	doxycycline	GALDERMA LABS LP	NDA050805
May 25, 2006	SEASONIQUE	ethinyl estradiol, levonorgestrel	TEVA BRANDED PHARM	NDA021840
May 25, 2006	THALOMID	thalidomide	CELGENE	NDA021430
May 22, 2006	IONSYS	fentanyl hydrochloride	THE MEDICINES CO	NDA021338
May 22, 2006	QOLIANA	brimonidine tartrate	SANDOZ	NDA021764
May 19, 2006	SARAFEM	fluoxetine hydrochloride	APIL	NDA021860
May 16, 2006	AZILECT	rasagiline mesylate	TEVA	NDA021641
May 10, 2006	CHANTIX	varenicline tartrate	PF PRISM CV	NDA021928
May 8, 2006	SOLODYN	minocycline hydrochloride	BAUSCH	NDA050808
May 2, 2006	DACOGEN	decitabine	OTSUKA	NDA021790
April 28, 2006	MYOZYME	alglucosidase alfa	GENZYME	BLA125141
April 13, 2006	NEOPROFEN	ibuprofen lysine	RECORDATI RARE	NDA021903
April 13, 2006	VIVITROL	naltrexone	ALKERMES	NDA021897
April 6, 2006	DAYTRANA	methylphenidate	NOVEN PHARMS INC	NDA021514
March 30, 2006	SEPTOCAINE	articaine hydrochloride, epinephrine bitartrate	DEPROCO	NDA022010
March 29, 2006	GEODON	ziprasidone hydrochloride	PFIZER INC	NDA021483
March 28, 2006	FLUORESCITE	fluorescein sodium	ALCON LABS INC	NDA021980
March 24, 2006	ZEGERID	magnesium hydroxide, omeprazole, sodium bicarbonate	SANTARUS	NDA021850
March 16, 2006	OSMOPREP	sodium phosphate, dibasic, anhydrous, sodium phosphate, monobasic, monohydrate	SALIX PHARMS	NDA021892
March 16, 2006	YAZ	drospirenone, ethinyl estradiol	BAYER HLTHCARE	NDA021676
March 10, 2006	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	cefoxitin sodium	B BRAUN	NDA065214
February 27, 2006	EMSAM	selegiline	SOMERSET	NDA021336
February 27, 2006	EMSAM	selegiline	SOMERSET	NDA021708
February 27, 2006	ZEGERID	omeprazole, sodium bicarbonate	SALIX	NDA021849
February 17, 2006	ERAXIS	anidulafungin	VICURON HOLDINGS	NDA021632
February 17, 2006	ERAXIS	anidulafungin	PFIZER	NDA021948
February 17, 2006	LOESTRIN 24 FE	ethinyl estradiol, norethindrone acetate	TEVA BRANDED PHARM	NDA021871
February 17, 2006	NAPROXEN SODIUM	naproxen sodium	BIONPHARMA	NDA021920
February 16, 2006	VUSION	miconazole nitrate, white petrolatum, zinc oxide	MYLAN	NDA021026
February 1, 2006	CLARINEX-D 12 HOUR	desloratadine, pseudoephedrine sulfate	ORGANON LLC	NDA021313
January 31, 2006	AMITIZA	lubiprostone	SUCAMPO PHARMA LLC	NDA021908
January 27, 2006	AEROSPAN HFA	flunisolide	PHARMOBEDIENT	NDA021247
January 27, 2006	RANEXA	ranolazine	MENARINI INTL	NDA021526
January 26, 2006	SUTENT	sunitinib malate	CPPI CV	NDA021938
January 26, 2006	SUTENT	sunitinib malate	CPPI CV	NDA021968
January 20, 2006	MEN'S ROGAINE	minoxidil	KENVUE BRANDS	NDA021812
January 11, 2006	LIPOFEN	fenofibrate	CIPHER PHARMS INC	NDA021612
January 9, 2006	TACLONEX	betamethasone dipropionate, calcipotriene	LEO PHARMA AS	NDA021852
January 6, 2006	BONIVA	ibandronate sodium	ROCHE	NDA021858