FDA data · free, no account

FDA drug approvals in 2004

FDA approved the original submission of 116 new drug and biologics license applications in 2004, from 96 sponsors. FDA marks 55 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 30, 2004	LYRICA	pregabalin	UPJOHN	NDA021446
December 30, 2004	LYRICA	pregabalin	CP PHARMS	NDA021723
December 29, 2004	VENTAVIS	iloprost	ACTELION	NDA021779
December 28, 2004	CLOLAR	clofarabine	GENZYME	NDA021673
December 28, 2004	PRIALT	ziconotide acetate	ESTEVE	NDA021060
December 22, 2004	ENABLEX	darifenacin hydrobromide	ABBVIE	NDA021513
December 22, 2004	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	ALCON LABS INC	NDA021545
December 21, 2004	ZEGERID	omeprazole, sodium bicarbonate	SANTARUS	NDA021706
December 20, 2004	ENJUVIA	estrogens, conjugated synthetic b	DURAMED	NDA021609
December 17, 2004	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	PFIZER	NDA021583
December 17, 2004	INVIRASE	saquinavir mesylate	HOFFMANN-LA ROCHE	NDA021785
December 16, 2004	VISIONBLUE	trypan blue	DORC	NDA021670
December 15, 2004	KEPIVANCE	palifermin	BIOVITRUM AB	BLA125103
December 15, 2004	LUNESTA	eszopiclone	WAYLIS THERAP	NDA021476
December 14, 2004	ELIGARD KIT	leuprolide acetate	TOLMAR	NDA021731
December 14, 2004	ZYLET	loteprednol etabonate, tobramycin	BAUSCH AND LOMB	NDA050804
December 10, 2004	ABILIFY	aripiprazole	OTSUKA	NDA021713
December 10, 2004	EQUETRO	carbamazepine	VALIDUS PHARMS	NDA021710
November 30, 2004	ANTARA (MICRONIZED)	fenofibrate	LUPIN	NDA021695
November 30, 2004	CLINDESSE	clindamycin phosphate	PADAGIS US	NDA050793
November 26, 2004	COMBUNOX	ibuprofen, oxycodone hydrochloride	FOREST LABS	NDA021378
November 23, 2004	MULTIHANCE	gadobenate dimeglumine	BRACCO	NDA021357
November 23, 2004	MULTIHANCE MULTIPACK	gadobenate dimeglumine	BRACCO	NDA021358
November 23, 2004	TYSABRI	natalizumab	BIOGEN IDEC	BLA125104
November 19, 2004	VESICARE	solifenacin succinate	ASTELLAS	NDA021518
November 18, 2004	TARCEVA	erlotinib hydrochloride	OSI PHARMS	NDA021743
November 17, 2004	ATROVENT HFA	ipratropium bromide	BOEHRINGER INGELHEIM	NDA021527
November 10, 2004	LOVAZA	omega-3-acid ethyl esters	WAYLIS THERAP	NDA021654
November 5, 2004	TRICOR	fenofibrate	ABBVIE	NDA021656
October 29, 2004	MENOPUR	menotropins (fsh, lh)	FERRING	BLA021663
October 29, 2004	PROAIR HFA	albuterol sulfate	TEVA BRANDED PHARM	NDA021457
October 26, 2004	AMPHADASE	hyaluronidase	AMPHASTAR PHARM	BLA021665
October 26, 2004	FOSRENOL	lanthanum carbonate	TAKEDA PHARMS USA	NDA021468
October 26, 2004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine, lidocaine hydrochloride	EMPI	NDA021486
October 22, 2004	EVOCLIN	clindamycin phosphate	QUAGEN	NDA050801
October 21, 2004	LEVAQUIN	levofloxacin	JANSSEN PHARMS	NDA021721
October 19, 2004	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride, pseudoephedrine hydrochloride	CHATTEM SANOFI	NDA021704
October 18, 2004	ARICEPT	donepezil hydrochloride	EISAI INC	NDA021719
October 18, 2004	ARICEPT ODT	donepezil hydrochloride	EISAI INC	NDA021720
October 12, 2004	VANTAS	histrelin acetate	ENDO OPERATIONS	NDA021732
October 1, 2004	TERCONAZOLE	terconazole	FOUGERA	NDA021735
September 29, 2004	AMLEXANOX	amlexanox	ULURU	NDA021727
September 24, 2004	FLUXID	famotidine	UCB INC	NDA021712
September 24, 2004	PALLADONE	hydromorphone hydrochloride	PURDUE PHARMA LP	NDA021044
September 17, 2004	MACUGEN	pegaptanib sodium	BAUSCH AND LOMB INC	NDA021756
September 3, 2004	CYMBALTA	duloxetine hydrochloride	LILLY	NDA021733
September 1, 2004	CLARINEX	desloratadine	ORGANON LLC	NDA021300
September 1, 2004	CLARINEX	desloratadine	SCHERING	NDA021563
August 31, 2004	ZANTAC 150	ranitidine hydrochloride	CHATTEM SANOFI	NDA021698
August 26, 2004	DIGOXIN	digoxin	HIKMA	NDA021648
August 20, 2004	FEMTRACE	estradiol acetate	APIL	NDA021633
August 19, 2004	ALIMTA	pemetrexed	LILLY	NDA021677
August 11, 2004	PENTETATE CALCIUM TRISODIUM	pentetate calcium trisodium	HAMELN	NDA021749
August 11, 2004	PENTETATE ZINC TRISODIUM	pentetate zinc trisodium	HAMELN PHARMA PLUS	NDA021751
August 5, 2004	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	WEILL MEDCL COLL	NDA021768
August 3, 2004	CYMBALTA	duloxetine hydrochloride	LILLY	NDA021427
August 2, 2004	EPZICOM	abacavir sulfate, lamivudine	VIIV HLTHCARE	NDA021652
August 2, 2004	TRUVADA	emtricitabine, tenofovir disoproxil fumarate	GILEAD	NDA021752
July 29, 2004	CAMPRAL	acamprosate calcium	FOREST LABS	NDA021431
July 29, 2004	CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER	cefotaxime sodium	B BRAUN	NDA050792
July 27, 2004	METVIXIA	methyl aminolevulinate hydrochloride	GALDERMA LABS LP	NDA021415
July 23, 2004	VYTORIN	ezetimibe, simvastatin	ORGANON	NDA021687
July 21, 2004	ALINIA	nitazoxanide	ROMARK	NDA021497
July 13, 2004	TOBRAMYCIN SULFATE	tobramycin sulfate	FRESENIUS KABI USA	NDA050789
June 24, 2004	LORATADINE	loratadine	PERRIGO	NDA021512
June 22, 2004	MUCINEX D	guaifenesin, pseudoephedrine hydrochloride	RECKITT BENCKISER	NDA021585
June 21, 2004	CODEPREX	chlorpheniramine polistirex, codeine polistirex	LANNETT CO INC	NDA021369
June 15, 2004	ZEGERID	omeprazole, sodium bicarbonate	SALIX	NDA021636
June 10, 2004	NUTRESTORE	l-glutamine	EMMAUS MEDCL	NDA021667
June 8, 2004	MENOSTAR	estradiol	BAYER HLTHCARE	NDA021674
June 4, 2004	ISTALOL	timolol maleate	BAUSCH AND LOMB	NDA021516
June 1, 2004	MELOXICAM	meloxicam	AVONDALE PHARMS	NDA021530
May 28, 2004	SANCTURA	trospium chloride	ALLERGAN	NDA021595
May 27, 2004	PREVACID IV	lansoprazole	TAKEDA PHARMS NA	NDA021566
May 25, 2004	AXID	nizatidine	BRAINTREE	NDA021494
May 25, 2004	GONAL-F RFF REDI-JECT	follitropin alfa/beta	EMD SERONO	BLA021684
May 25, 2004	XIFAXAN	rifaximin	SALIX PHARMS	NDA021361
May 19, 2004	VIDAZA	azacitidine	BRISTOL-MYERS	NDA050794
May 18, 2004	DEPODUR	morphine sulfate	PACIRA PHARMS INC	NDA021671
May 17, 2004	TINDAMAX	tinidazole	MISSION PHARMA	NDA021618
May 17, 2004	TINDAMAX	tinidazole	MISSION PHARMA	NDA021681
May 17, 2004	TINDAMAX	tinidazole	MISSION PHARMA	NDA021682
May 14, 2004	FLOVENT HFA	fluticasone propionate	GLAXO GRP LTD	NDA021433
May 10, 2004	ENJUVIA	estrogens, conjugated synthetic b	ASPEN	NDA021443
May 10, 2004	HALFLYTELY	bisacodyl, polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride	BRAINTREE	NDA021551
May 6, 2004	LIDOSITE TOPICAL SYSTEM KIT	epinephrine, lidocaine hydrochloride	VYTERIS	NDA021504
May 5, 2004	VITRASE	hyaluronidase	BAUSCH AND LOMB	BLA021640
April 29, 2004	MUCINEX DM	dextromethorphan hydrobromide, guaifenesin	RECKITT BENCKISER	NDA021620
April 27, 2004	FORTAMET	metformin hydrochloride	ANDRX LABS LLC	NDA021574
April 20, 2004	APOKYN	apomorphine hydrochloride	MDD US	NDA021264
April 16, 2004	APIDRA SOLOSTAR	insulin glulisine recombinant	SANOFI AVENTIS US	BLA021629
April 9, 2004	CHIRHOSTIM	secretin synthetic human	CHIRHOCLIN	NDA021256
April 7, 2004	NASACORT HFA	triamcinolone acetonide	SANOFI AVENTIS US	NDA020784
April 1, 2004	KETEK	telithromycin	SANOFI AVENTIS US	NDA021144
March 29, 2004	ZYPREXA	olanzapine	CHEPLAPHARM	NDA021253
March 26, 2004	VIOXX	rofecoxib	MERCK	NDA021647
March 25, 2004	GONAL-F	follitropin alfa/beta	EMD SERONO	BLA021765
March 23, 2004	FOLLISTIM AQ	follitropin alfa/beta	ORGANON USA LLC	BLA021211
March 16, 2004	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	KENVUE BRANDS	NDA021621
March 8, 2004	SENSIPAR	cinacalcet hydrochloride	AMGEN	NDA021688
March 1, 2004	IQUIX	levofloxacin	SANTEN	NDA021571
February 27, 2004	MYFORTIC	mycophenolate sodium	NOVARTIS	NDA050791
February 26, 2004	AVASTIN	bevacizumab	GENENTECH	BLA125085
February 24, 2004	CHILDREN'S ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine hydrochloride	HALEON US HOLDINGS	NDA021587
February 18, 2004	M.V.I. ADULT (PHARMACY BULK PACKAGE)	ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a, vitamin e, vitamin k	HOSPIRA	NDA021643
February 12, 2004	ERBITUX	cetuximab	IMCLONE	BLA125084
February 10, 2004	FAZACLO ODT	clozapine	JAZZ	NDA021590
February 9, 2004	ESTROGEL	estradiol	ASCEND THERAPS US	NDA021166
February 5, 2004	CLOBEX	clobetasol propionate	GALDERMA LABS	NDA021644
February 4, 2004	ALIMTA	pemetrexed disodium	LILLY	NDA021462
February 4, 2004	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INTL MEDICATION SYS	NDA021594
January 30, 2004	CADUET	amlodipine besylate, atorvastatin calcium	PHARMACIA	NDA021540
January 30, 2004	M.V.I. ADULT	ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a, vitamin e, vitamin k	HOSPIRA	NDA021625
January 30, 2004	SPIRIVA	tiotropium bromide	BOEHRINGER INGELHEIM	NDA021395
January 23, 2004	ACETADOTE	acetylcysteine	APOTEX	NDA021539
January 7, 2004	CHILDREN'S ELIXSURE	ibuprofen	MOBERG PHARMA NORTH	NDA021604