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FDA drug approvals in 2001

FDA approved the original submission of 73 new drug and biologics license applications in 2001, from 54 sponsors. FDA marks 32 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 21, 2001	CLARINEX	desloratadine	ORGANON	NDA021165
December 13, 2001	ELIDEL	pimecrolimus	BAUSCH	NDA021302
December 7, 2001	ARIXTRA	fondaparinux sodium	MYLAN IRELAND LTD	NDA021345
December 7, 2001	LOTRIMIN ULTRA	butenafine hydrochloride	BAYER HEALTHCARE LLC	NDA021307
November 30, 2001	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	BAYER HLTHCARE	NDA021277
November 21, 2001	INVANZ	ertapenem sodium	MSD SUB MERCK	NDA021337
November 20, 2001	AVODART	dutasteride	WAYLIS THERAP	NDA021319
November 20, 2001	ORTHO EVRA	ethinyl estradiol, norelgestromin	JANSSEN PHARMS	NDA021180
November 20, 2001	TRACLEER	bosentan	ACTELION	NDA021290
November 16, 2001	BEXTRA	valdecoxib	GD SEARLE	NDA021341
November 14, 2001	KINERET	anakinra	BIOVITRUM AB	BLA103950
November 13, 2001	FOCALIN	dexmethylphenidate hydrochloride	SANDOZ	NDA021278
November 8, 2001	FROVA	frovatriptan succinate	ENDO OPERATIONS	NDA021006
November 1, 2001	NOVOLOG MIX 70/30 PENFILL	insulin aspart protamine recombinant, insulin aspart recombinant	NOVO NORDISK INC	BLA021172
November 1, 2001	TEVETEN HCT	eprosartan mesylate, hydrochlorothiazide	ABBVIE	NDA021268
October 26, 2001	VIREAD	tenofovir disoproxil fumarate	GILEAD SCIENCES INC	NDA021356
October 18, 2001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	aspirin	BAYER	NDA021317
October 11, 2001	ADDERALL XR 10	amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate	TAKEDA PHARMS USA	NDA021303
October 3, 2001	NUVARING	ethinyl estradiol, etonogestrel	ORGANON USA ORGANON	NDA021187
October 2, 2001	ENTOCORT EC	budesonide	PADAGIS US	NDA021324
September 25, 2001	FORADIL	formoterol fumarate	NOVARTIS	NDA021279
September 17, 2001	ARANESP	darbepoetin alfa	AMGEN	BLA103951
September 17, 2001	CORTISONE ACETATE	cortisone acetate	IMPAX LABS	NDA009458
September 4, 2001	TRICOR	fenofibrate	ABBVIE	NDA021203
August 29, 2001	SPECTRACEF	cefditoren pivoxil	VANSEN PHARMA	NDA021222
August 20, 2001	ZOMETA	zoledronic acid	NOVARTIS	NDA021223
August 15, 2001	ULTRACET	acetaminophen, tramadol hydrochloride	JANSSEN PHARMS	NDA021123
August 10, 2001	NATRECOR	nesiritide	SCIOS LLC	NDA020920
August 10, 2001	ZYRTEC-D 12 HOUR	cetirizine hydrochloride, pseudoephedrine hydrochloride	KENVUE BRANDS	NDA021150
July 31, 2001	DEFINITY	perflutren	LANTHEUS MEDCL	NDA021064
July 18, 2001	DIOVAN	valsartan	NOVARTIS	NDA021283
July 9, 2001	ATROPINE SULFATE	atropine sulfate	HOSPIRA	NDA021146
June 29, 2001	MONISTAT 1 COMBINATION PACK	miconazole nitrate	MEDTECH PRODUCTS	NDA021308
June 29, 2001	TRELSTAR	triptorelin pamoate	VERITY	NDA021288
June 27, 2001	KYTRIL	granisetron hydrochloride	ROCHE	NDA021238
June 26, 2001	SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE	phenazopyridine hydrochloride, sulfamethoxazole, trimethoprim	ABLE	NDA021105
June 22, 2001	AUGMENTIN ES-600	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050755
June 22, 2001	RAZADYNE	galantamine hydrobromide	JANSSEN PHARMS	NDA021224
June 7, 2001	AVAGARD	alcohol, chlorhexidine gluconate	SOLVENTUM	NDA021074
May 25, 2001	LEVOXYL	levothyroxine sodium	KING PHARMS	NDA021301
May 25, 2001	TRILEPTAL	oxcarbazepine	NOVARTIS	NDA021285
May 11, 2001	YASMIN	drospirenone, ethinyl estradiol	BAYER HLTHCARE	NDA021098
May 10, 2001	GLEEVEC	imatinib mesylate	NOVARTIS	NDA021335
May 7, 2001	AXERT	almotriptan malate	JANSSEN PHARMS	NDA021001
May 7, 2001	LEMTRADA	alemtuzumab	GENZYME	BLA103948
May 3, 2001	PREVACID	lansoprazole	TAKEDA PHARMS NA	NDA021281
April 30, 2001	ACCUNEB	albuterol sulfate	PHARMOBEDIENT	NDA020949
April 27, 2001	AVELOX	moxifloxacin hydrochloride	BAYER PHARMS	NDA021334
April 19, 2001	VENTOLIN HFA	albuterol sulfate	GLAXOSMITHKLINE	NDA020983
April 3, 2001	METADATE CD	methylphenidate hydrochloride	LANNETT	NDA021259
April 2, 2001	PHOSLO GELCAPS	calcium acetate	FRESENIUS MEDCL CARE	NDA021160
March 29, 2001	VALCYTE	valganciclovir hydrochloride	CHEPLAPHARM	NDA021304
March 22, 2001	PROTONIX IV	pantoprazole sodium	WYETH PHARMS	NDA020988
March 21, 2001	DUONEB	albuterol sulfate, ipratropium bromide	PHARMOBEDIENT	NDA020950
March 16, 2001	ALPHAGAN P	brimonidine tartrate	ABBVIE	NDA021262
March 16, 2001	LUMIGAN	bimatoprost	ABBVIE	NDA021275
March 16, 2001	TRAVATAN	travoprost	ALCON PHARMS LTD	NDA021257
March 1, 2001	TAVIST ALLERGY/SINUS/HEADACHE	acetaminophen, clemastine fumarate, pseudoephedrine hydrochloride	NOVARTIS	NDA021082
February 28, 2001	RAZADYNE	galantamine hydrobromide	JANSSEN PHARMS	NDA021169
February 26, 2001	PROZAC WEEKLY	fluoxetine hydrochloride	LILLY	NDA021235
February 21, 2001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	cefuroxime sodium	B BRAUN	NDA050780
February 21, 2001	INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)	ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin a, vitamin k	SANDOZ CANADA INC	NDA021265
February 20, 2001	NEXIUM	esomeprazole magnesium	ASTRAZENECA	NDA021153
February 16, 2001	ARESTIN	minocycline hydrochloride	ORAPHARMA	NDA050781
February 16, 2001	FORADIL	formoterol fumarate	NOVARTIS	NDA020831
February 13, 2001	ZOMIG-ZMT	zolmitriptan	ASTRAZENECA	NDA021231
February 5, 2001	GEODON	ziprasidone hydrochloride	VIATRIS	NDA020825
February 2, 2001	MONISTAT 3 COMBINATION PACK	miconazole nitrate	MEDTECH PRODUCTS	NDA021261
February 2, 2001	PERIOSTAT	doxycycline hyclate	GALDERMA LABS LP	NDA050783
January 26, 2001	CANCIDAS	caspofungin acetate	MERCK	NDA021227
January 19, 2001	PEGINTRON	peginterferon alfa-2b	SCHERING	BLA103949
January 12, 2001	REMERON SOLTAB	mirtazapine	ORGANON USA ORGANON	NDA021208
January 5, 2001	CANASA	mesalamine	ABBVIE	NDA021252