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FDA drug approvals in 1984

FDA approved the original submission of 109 new drug and biologics license applications in 1984, from 65 sponsors. FDA marks 69 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 1984	LOPRESSOR HCT	hydrochlorothiazide, metoprolol tartrate	VALIDUS PHARMS	NDA018303
December 31, 1984	MODRASTANE	trilostane	BIOENVISION	NDA018719
December 28, 1984	NEPHROFLOW	iodohippurate sodium i-123	GE HEALTHCARE	NDA018289
December 28, 1984	SECTRAL	acebutolol hydrochloride	PROMIUS PHARMA	NDA018917
December 28, 1984	TORNALATE	bitolterol mesylate	SANOFI AVENTIS US	NDA018770
December 27, 1984	ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, magnesium chloride, potassium chloride, potassium phosphate, dibasic, sodium acetate	B BRAUN	NDA019025
December 24, 1984	DYNA-HEX 4	chlorhexidine gluconate	XTTRIUM	NDA019125
December 24, 1984	EXIDINE	chlorhexidine gluconate	XTTRIUM	NDA019127
December 21, 1984	ROCEPHIN KIT	ceftriaxone sodium, lidocaine	HOFFMANN LA ROCHE	NDA050585
December 14, 1984	DESOWEN	desonide	GALDERMA LABS LP	NDA019048
December 14, 1984	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	HOSPIRA INC	NDA019211
December 12, 1984	AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	aminophylline	HOSPIRA	NDA018924
November 30, 1984	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate	FRESENIUS MEDCL	NDA018883
November 20, 1984	REVIA	naltrexone hydrochloride	TEVA WOMENS	NDA018932
November 15, 1984	PARAGARD T 380A	copper	COOPERSURGICAL	NDA018680
November 9, 1984	TONOCARD	tocainide hydrochloride	ASTRAZENECA	NDA018257
November 7, 1984	THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	B BRAUN	NDA019083
November 7, 1984	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	B BRAUN	NDA019212
November 1, 1984	TRIPHASIL-21	ethinyl estradiol, levonorgestrel	WYETH PHARMS	NDA019192
November 1, 1984	TRIPHASIL-28	ethinyl estradiol, levonorgestrel	WYETH PHARMS INC	NDA019190
October 26, 1984	BENZAMYCIN	benzoyl peroxide, erythromycin	VALEANT INTL	NDA050557
October 26, 1984	COLYTE-FLAVORED	polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous	STRIDES PHARMA INTL	NDA018983
October 22, 1984	MAXZIDE-25	hydrochlorothiazide, triamterene	AUROBINDO PHARMA USA	NDA019129
October 19, 1984	ZANTAC	ranitidine hydrochloride	PAI HOLDINGS PHARM	NDA019090
October 16, 1984	PENTAM	pentamidine isethionate	FRESENIUS KABI USA	NDA019264
October 12, 1984	CAPOZIDE 50/25	captopril, hydrochlorothiazide	APOTHECON	NDA018709
October 10, 1984	CATAPRES-TTS-3	clonidine	LAVIPHARM	NDA018891
October 3, 1984	CEFIZOX IN PLASTIC CONTAINER	ceftizoxime sodium	ASTELLAS	NDA050589
October 3, 1984	OPTICROM	cromolyn sodium	ALLERGAN	NDA018155
October 3, 1984	TOLAZAMIDE	tolazamide	COSETTE	NDA018894
October 1, 1984	PILOPINE HS	pilocarpine hydrochloride	ALCON	NDA018796
September 28, 1984	ALLOPURINOL	allopurinol	WATSON LABS	NDA018832
September 28, 1984	ALLOPURINOL	allopurinol	WATSON LABS	NDA018877
September 28, 1984	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	BAXTER HLTHCARE	NDA018684
September 25, 1984	LIPOSYN III 20%	soybean oil	HOSPIRA	NDA018970
September 24, 1984	LIPOSYN III 10%	soybean oil	HOSPIRA	NDA018969
September 18, 1984	DURAMORPH PF	morphine sulfate	HIKMA	NDA018565
September 10, 1984	CALAN	verapamil hydrochloride	PFIZER	NDA018817
September 5, 1984	SODIUM LACTATE IN PLASTIC CONTAINER	sodium lactate	HOSPIRA	NDA018947
September 4, 1984	ALPHATREX	betamethasone dipropionate	SAVAGE LABS	NDA019143
September 4, 1984	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	FOUGERA	NDA019141
August 30, 1984	TRENTAL	pentoxifylline	VALIDUS PHARMS	NDA018631
August 27, 1984	LIPOSYN II 10%	safflower oil, soybean oil	HOSPIRA	NDA018997
August 27, 1984	LIPOSYN II 20%	safflower oil, soybean oil	HOSPIRA	NDA018991
August 24, 1984	DIMETANE-DX	brompheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride	ROBINS AH	NDA019279
August 23, 1984	TRAVASOL 10% IN PLASTIC CONTAINER	amino acids	BAXTER HLTHCARE	NDA018931
August 17, 1984	AEROBID	flunisolide	ROCHE PALO	NDA018340
August 15, 1984	MONISTAT 3	miconazole nitrate	MEDTECH PRODUCTS	NDA018888
August 13, 1984	INDOCIN	indomethacin	COSETTE	NDA017814
August 6, 1984	AUGMENTIN '125'	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050575
August 6, 1984	AUGMENTIN '250'	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050564
August 6, 1984	INDOMETHACIN	indomethacin	CHARTWELL MOLECULES	NDA018829
August 1, 1984	NORMODYNE	labetalol hydrochloride	SCHERING	NDA018686
August 1, 1984	NORMODYNE	labetalol hydrochloride	SCHERING	NDA018687
August 1, 1984	TRANDATE	labetalol hydrochloride	ALVOGEN	NDA018716
July 31, 1984	IMODIUM	loperamide hydrochloride	JANSSEN PHARMS	NDA019037
July 31, 1984	INOCOR	inamrinone lactate	SANOFI AVENTIS US	NDA018700
July 31, 1984	ORAP	pimozide	TEVA	NDA017473
July 20, 1984	POTASSIUM ACETATE	potassium acetate	HOSPIRA	NDA018896
July 20, 1984	SODIUM CHLORIDE 14.6%	sodium chloride	HOSPIRA	NDA018897
July 20, 1984	TPN ELECTROLYTES IN PLASTIC CONTAINER	calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride	HOSPIRA	NDA018895
July 20, 1984	TROPHAMINE 10%	amino acids	B BRAUN	NDA019018
July 13, 1984	DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	ICU MEDICAL INC	NDA019222
July 13, 1984	GOLYTELY	polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous	AZURITY	NDA019011
July 13, 1984	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	ICU MEDICAL INC	NDA019217
July 11, 1984	FENTANYL CITRATE	fentanyl citrate	HIKMA	NDA019101
July 10, 1984	LOTRISONE	betamethasone dipropionate, clotrimazole	ORGANON	NDA018827
June 29, 1984	METHYLDOPA	methyldopa	CHARTWELL RX	NDA018934
June 26, 1984	ALPHATREX	betamethasone dipropionate	SAVAGE LABS	NDA019138
June 26, 1984	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	FOUGERA	NDA019137
June 26, 1984	FLUOCINONIDE	fluocinonide	SUN PHARMA CANADA	NDA019117
June 15, 1984	PLASMA-LYTE 56 IN PLASTIC CONTAINER	magnesium acetate tetrahydrate, potassium acetate, sodium chloride	BAXTER HLTHCARE	NDA019047
June 8, 1984	PHYSIOLYTE IN PLASTIC CONTAINER	magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate	B BRAUN	NDA019024
June 8, 1984	TENORETIC 100	atenolol, chlorthalidone	TWI PHARMS	NDA018760
May 24, 1984	PRECEF	ceforanide	BRISTOL	NDA050554
May 22, 1984	FUROSEMIDE	furosemide	FRESENIUS KABI USA	NDA018902
May 18, 1984	ADVIL	ibuprofen	HALEON US HOLDINGS	NDA018989
May 18, 1984	INDOMETHACIN	indomethacin	HERITAGE	NDA018851
May 18, 1984	MOTRIN MIGRAINE PAIN	ibuprofen	KENVUE BRANDS	NDA019012
May 8, 1984	GLUCOTROL	glipizide	PFIZER	NDA017783
May 4, 1984	INDOMETHACIN	indomethacin	IVAX SUB TEVA PHARMS	NDA018730
May 4, 1984	MARCAINE	bupivacaine hydrochloride	HOSPIRA	NDA018692
May 4, 1984	SUFENTA PRESERVATIVE FREE	sufentanil citrate	RISING	NDA019050
May 1, 1984	DIABETA	glyburide	SANOFI AVENTIS US	NDA017532
May 1, 1984	MICRONASE	glyburide	PFIZER	NDA017498
April 30, 1984	NORCURON	vecuronium bromide	ORGANON USA INC	NDA018776
April 20, 1984	INDOMETHACIN	indomethacin	RISING	NDA018858
April 11, 1984	TRI-NORINYL 28-DAY	ethinyl estradiol, norethindrone	DR REDDYS LABS SA	NDA018977
April 10, 1984	METRONIDAZOLE	metronidazole	LNK	NDA019029
April 6, 1984	AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE	amino acids	HOSPIRA	NDA018901
April 6, 1984	LIDEX	fluocinonide	ALVOGEN	NDA018849
April 4, 1984	ORTHO-NOVUM 7/14-21	ethinyl estradiol, norethindrone	ORTHO MCNEIL PHARM	NDA019004
April 4, 1984	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol, norethindrone	JANSSEN PHARMS	NDA018985
April 3, 1984	LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride, sodium lactate	BAXTER HLTHCARE	NDA018921
April 2, 1984	ISOLYTE S PH 7.4 IN PLASTIC CONTAINER	magnesium chloride, potassium chloride, potassium phosphate, monobasic, sodium acetate, sodium chloride, sodium gluconate, sodium phosphate, dibasic, heptahydrate	B BRAUN	NDA019006
March 30, 1984	CALAN	verapamil hydrochloride	GD SEARLE LLC	NDA019038
March 30, 1984	DDAVP	desmopressin acetate	J MOLNER	NDA018938
March 30, 1984	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	B BRAUN	NDA018967
March 30, 1984	LOPRESSOR	metoprolol tartrate	NOVARTIS	NDA018704
March 30, 1984	METRONIDAZOLE	metronidazole	HIKMA	NDA018907
March 30, 1984	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	EXELA PHARMA	NDA018925
March 2, 1984	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	B BRAUN	NDA019077
February 28, 1984	FUROSEMIDE	furosemide	INTL MEDICATION	NDA018753
February 17, 1984	LOTRIMIN	clotrimazole	SCHERING	NDA018813
January 31, 1984	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	HOSPIRA	NDA018916
January 17, 1984	NEOPHAM 6.4%	amino acids	HOSPIRA	NDA018792
January 13, 1984	NICORETTE	nicotine polacrilex	HALEON US HOLDINGS	NDA018612
January 11, 1984	DILAUDID-HP	hydromorphone hydrochloride	FRESENIUS KABI USA	NDA019034
January 4, 1984	CORSYM	chlorpheniramine polistirex, phenylpropanolamine polistirex	UCB INC	NDA018050