FDA data · free, no account

FDA drug approvals in 1997

FDA approved the original submission of 125 new drug and biologics license applications in 1997, from 83 sponsors. FDA marks 74 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 1997	OPTISON	albumin human	GE HEALTHCARE	NDA020899
December 29, 1997	EMADINE	emedastine difumarate	NOVARTIS	NDA020706
December 24, 1997	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride, pseudoephedrine hydrochloride	CHATTEM SANOFI	NDA020786
December 24, 1997	ARTHROTEC	diclofenac sodium, misoprostol	PFIZER	NDA020607
December 24, 1997	SCLEROSOL	talc	SCIARRA LABS	NDA020587
December 23, 1997	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	ROCHE	NDA020813
December 22, 1997	PRANDIN	repaglinide	GEMINI LABS LLC	NDA020741
December 22, 1997	TEVETEN	eprosartan mesylate	ABBVIE	NDA020738
December 22, 1997	TOBI	tobramycin	VIATRIS	NDA050753
December 19, 1997	LUMENHANCE	manganese chloride tetrahydrate	BRACCO	NDA020686
December 19, 1997	PROPECIA	finasteride	ORGANON	NDA020788
December 18, 1997	TESTODERM TTS	testosterone	ALZA	NDA020791
December 18, 1997	TROVAN	trovafloxacin mesylate	PFIZER	NDA020759
December 18, 1997	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	PFIZER	NDA020760
December 16, 1997	FLOXIN OTIC	ofloxacin	DAIICHI	NDA020799
December 16, 1997	REGRANEX	becaplermin	SMITH AND NEPHEW	BLA103691
December 11, 1997	BACTROBAN	mupirocin calcium	GLAXOSMITHKLINE	NDA050746
December 10, 1997	BSS	calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate	ALCON	NDA020742
December 10, 1997	URSO 250	ursodiol	ABBVIE	NDA020675
December 9, 1997	EVISTA	raloxifene hydrochloride	LILLY	NDA020815
December 8, 1997	MIGRANAL	dihydroergotamine mesylate	BAUSCH	NDA020148
December 4, 1997	ANTIZOL	fomepizole	PAR PHARM INC	NDA020696
December 4, 1997	OMNICEF	cefdinir	ABBVIE	NDA050739
December 4, 1997	OMNICEF	cefdinir	ABBVIE	NDA050749
December 2, 1997	PREVPAC (COPACKAGED)	amoxicillin, clarithromycin, lansoprazole	TAKEDA PHARMS USA	NDA050757
November 26, 1997	FLAGYL ER	metronidazole	PFIZER	NDA020868
November 26, 1997	RITUXAN	rituximab	GENENTECH	BLA103705
November 26, 1997	TESLASCAN	mangafodipir trisodium	IC TARGETS	NDA020652
November 25, 1997	ZOMIG	zolmitriptan	IPR	NDA020768
November 22, 1997	MERIDIA	sibutramine hydrochloride	ABBOTT	NDA020632
November 17, 1997	PLAVIX	clopidogrel bisulfate	SANOFI AVENTIS US	NDA020839
November 14, 1997	ROGAINE EXTRA STRENGTH (FOR MEN)	minoxidil	KENVUE BRANDS	NDA020834
November 7, 1997	FLOVENT	fluticasone propionate	GLAXOSMITHKLINE	NDA020549
November 7, 1997	FORTOVASE	saquinavir	HOFFMANN LA ROCHE	NDA020828
November 7, 1997	PROPULSID QUICKSOLV	cisapride monohydrate	JANSSEN PHARMA	NDA020767
November 6, 1997	RAXAR	grepafloxacin hydrochloride	OTSUKA	NDA020695
November 3, 1997	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	ALLERGAN	NDA020811
October 31, 1997	CAVERJECT	alprostadil	PFIZER	NDA020755
October 20, 1997	EFFEXOR XR	venlafaxine hydrochloride	UPJOHN	NDA020699
October 17, 1997	LAMISIL	terbinafine hydrochloride	KARO HLTHCARE	NDA020749
October 14, 1997	FERRISELTZ	ferric ammonium citrate	OTSUKA	NDA020292
October 10, 1997	NIZORAL ANTI-DANDRUFF	ketoconazole	KRAMER	NDA020310
October 1, 1997	NASONEX	mometasone furoate	ORGANON LLC	NDA020762
October 1, 1997	TILADE	nedocromil sodium	SANOFI AVENTIS US	NDA020750
September 30, 1997	AVALIDE	hydrochlorothiazide, irbesartan	SANOFI AVENTIS US	NDA020758
September 30, 1997	AVAPRO	irbesartan	SANOFI AVENTIS US	NDA020757
September 30, 1997	CARBATROL	carbamazepine	TAKEDA PHARMS USA	NDA020712
September 30, 1997	GABITRIL	tiagabine hydrochloride	CEPHALON	NDA020646
September 30, 1997	LANOXIN	digoxin	ADVANZ PHARMA	NDA020405
September 29, 1997	CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER	amino acids, dextrose	BAXTER HLTHCARE	NDA020734
September 29, 1997	FOLLISTIM	follitropin alfa/beta	ORGANON USA INC	BLA020582
September 29, 1997	GONAL-F	follitropin alfa/beta	EMD SERONO	BLA020378
September 26, 1997	CIPRO	ciprofloxacin	BAYER HLTHCARE	NDA020780
September 26, 1997	COMBIVIR	lamivudine, zidovudine	VIIV HLTHCARE	NDA020857
September 26, 1997	GEREF	sermorelin acetate	EMD SERONO INC	NDA020443
September 26, 1997	NORITATE	metronidazole	BAUSCH	NDA020743
September 26, 1997	SEROQUEL	quetiapine fumarate	CHEPLAPHARM	NDA020639
September 23, 1997	CORLOPAM	fenoldopam mesylate	HOSPIRA	NDA019922
September 23, 1997	VICOPROFEN	hydrocodone bitartrate, ibuprofen	ABBVIE	NDA020716
September 19, 1997	REQUIP	ropinirole hydrochloride	GLAXOSMITHKLINE LLC	NDA020658
September 19, 1997	SEREVENT	salmeterol xinafoate	GLAXOSMITHKLINE	NDA020692
September 12, 1997	GENESA	arbutamine hydrochloride	GENSIA AUTOMEDICS	NDA020420
September 11, 1997	ANZEMET	dolasetron mesylate	VALIDUS PHARMS	NDA020623
September 11, 1997	ANZEMET	dolasetron mesylate	VALIDUS PHARMS	NDA020624
September 11, 1997	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	BAJAJ	NDA020111
September 8, 1997	LOCOID LIPOCREAM	hydrocortisone butyrate	PRECISION DERMAT	NDA020769
September 5, 1997	CARDIZEM	diltiazem hydrochloride	BIOVAIL	NDA020792
August 29, 1997	VISIPAQUE 270	iodixanol	GE HEALTHCARE	NDA020808
August 26, 1997	IMITREX	sumatriptan	GLAXOSMITHKLINE	NDA020626
August 11, 1997	AMBISOME	amphotericin b	ASTELLAS	NDA050740
July 31, 1997	CRINONE	progesterone	ABBVIE	NDA020701
July 29, 1997	DIASTAT ACUDIAL	diazepam	BAUSCH	NDA020648
July 28, 1997	NIASPAN TITRATION STARTER PACK	niacin	ABBVIE	NDA020381
July 25, 1997	FEMARA	letrozole	NOVARTIS PHARMS	NDA020726
July 24, 1997	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	J AND J CONSUMER INC	NDA020448
July 21, 1997	CICLOPIROX	ciclopirox	ALVOGEN	NDA020519
July 11, 1997	COLGATE TOTAL	sodium fluoride, triclosan	COLGATE PALMOLIVE	NDA020231
July 1, 1997	MIRAPEX	pramipexole dihydrochloride	BOEHRINGER INGELHEIM	NDA020667
June 27, 1997	UNIRETIC	hydrochlorothiazide, moexipril hydrochloride	UCB INC	NDA020729
June 26, 1997	BAYCOL	cerivastatin sodium	BAYER PHARMS	NDA020740
June 26, 1997	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride, simethicone	J AND J CONSUMER INC	NDA020606
June 25, 1997	BUTAZOLIDIN	phenylbutazone	NOVARTIS	NDA008319
June 25, 1997	HYDROCORTISONE ACETATE	hydrocortisone acetate	EPIC PHARMA LLC	NDA009637
June 25, 1997	PAXIL	paroxetine hydrochloride	APOTEX	NDA020710
June 24, 1997	PULMICORT	budesonide	ASTRAZENECA	NDA020441
June 19, 1997	CELLCEPT	mycophenolate mofetil	ROCHE PALO	NDA050723
June 19, 1997	NEORAL	cyclosporine	NOVARTIS	NDA050737
June 19, 1997	NEORAL	cyclosporine	NOVARTIS	NDA050738
June 13, 1997	TAZORAC	tazarotene	ALMIRALL	NDA020600
June 12, 1997	EDEX	alprostadil	ENDO OPERATIONS	NDA020649
May 29, 1997	FARESTON	toremifene citrate	KYOWA KIRIN	NDA020497
May 22, 1997	NEORAL	cyclosporine	NOVARTIS	NDA050735
May 22, 1997	NEORAL	cyclosporine	NOVARTIS	NDA050736
May 14, 1997	ZYBAN	bupropion hydrochloride	GLAXOSMITHKLINE	NDA020711
May 13, 1997	CRINONE	progesterone	WATSON LABS INC	NDA020756
May 9, 1997	PYTEST KIT	urea, c-14	AVENT	NDA020617
May 2, 1997	NICOTROL	nicotine	PFIZER	NDA020714
April 17, 1997	BETOPTIC PILO	betaxolol hydrochloride, pilocarpine hydrochloride	ALCON	NDA020619
April 15, 1997	FLOMAX	tamsulosin hydrochloride	SANOFI	NDA020579
April 4, 1997	RESCRIPTOR	delavirdine mesylate	VIIV HLTHCARE	NDA020705
March 28, 1997	QUADRAMET	samarium sm-153 lexidronam pentasodium	LANTHEUS MEDICAL	NDA020570
March 27, 1997	ALESSE	ethinyl estradiol, levonorgestrel	CADENCE HEALTH	NDA020683
March 26, 1997	CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER	amino acids, calcium chloride, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride	BAXTER HLTHCARE	NDA020678
March 14, 1997	AGRYLIN	anagrelide hydrochloride	TAKEDA PHARMS USA	NDA020333
March 14, 1997	VIRACEPT	nelfinavir mesylate	AGOURON PHARMS	NDA020778
March 14, 1997	VIRACEPT	nelfinavir mesylate	AGOURON PHARMS	NDA020779
March 13, 1997	ALPHAGAN	brimonidine tartrate	ALLERGAN	NDA020490
March 13, 1997	CONDYLOX	podofilox	ALLERGAN	NDA020529
March 7, 1997	LUPRON DEPOT	leuprolide acetate	ABBVIE ENDOCRINE INC	NDA020708
March 7, 1997	SKELID	tiludronate disodium	SANOFI AVENTIS US	NDA020707
March 3, 1997	DOVONEX	calcipotriene	LEO PHARM	NDA020611
February 28, 1997	PANDEL	hydrocortisone probutate	ANI PHARMS	NDA020453
February 27, 1997	ALDARA	imiquimod	BAUSCH	NDA020723
February 21, 1997	SPORANOX	itraconazole	JANSSEN PHARMS	NDA020657
February 17, 1997	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	PFIZER	NDA050734
February 11, 1997	VAGISTAT-1	tioconazole	COMBE	NDA020676
February 7, 1997	BUTOCONAZOLE NITRATE	butoconazole nitrate	PADAGIS US	NDA019881
February 7, 1997	RETIN-A-MICRO	tretinoin	BAUSCH	NDA020475
January 30, 1997	ZITHROMAX	azithromycin	PFIZER	NDA050733
January 29, 1997	PRELAY	troglitazone	SANKYO	NDA020719
January 29, 1997	REZULIN	troglitazone	PFIZER PHARMS	NDA020720
January 28, 1997	GALZIN	zinc acetate	ETON	NDA020458
January 24, 1997	ZOFRAN	ondansetron hydrochloride	SANDOZ	NDA020605
January 14, 1997	AVITA	tretinoin	MYLAN PHARMS INC	NDA020404
January 3, 1997	NASALCROM	cromolyn sodium	BLACKSMITH BRANDS	NDA020463