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FDA drug approvals in 1959

FDA approved the original submission of 49 new drug and biologics license applications in 1959, from 32 sponsors. FDA marks 38 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 23, 1959	PROLIXIN	fluphenazine hydrochloride	APOTHECON	NDA012145
December 21, 1959	COGENTIN	benztropine mesylate	EPIC PHARMA LLC	NDA012015
December 14, 1959	ORETICYL 50	deserpidine, hydrochlorothiazide	ABBVIE	NDA012148
December 7, 1959	NATURETIN-5	bendroflumethiazide	APOTHECON	NDA012164
November 16, 1959	CYTOXAN	cyclophosphamide	BAXTER HLTHCARE	NDA012141
November 16, 1959	CYTOXAN (LYOPHILIZED)	cyclophosphamide	BAXTER HLTHCARE	NDA012142
November 9, 1959	ISORDIL	isosorbide dinitrate	BAUSCH	NDA012093
November 4, 1959	NORFLEX	orphenadrine citrate	BAUSCH	NDA012157
October 30, 1959	DURABOLIN	nandrolone phenpropionate	ORGANON USA INC	NDA011891
October 6, 1959	DECADRON	dexamethasone sodium phosphate	MERCK	NDA012071
October 2, 1959	TOFRANIL	imipramine hydrochloride	NOVARTIS	NDA011838
September 23, 1959	PENTOTHAL	thiopental sodium	ABBOTT	NDA011679
September 9, 1959	PERMITIL	fluphenazine hydrochloride	SCHERING	NDA012034
September 8, 1959	AKINETON	biperiden hydrochloride	ABBVIE	NDA012003
September 2, 1959	ARISTOCORT	triamcinolone diacetate	ASTELLAS	NDA011960
September 2, 1959	DECADRON	dexamethasone sodium phosphate	MERCK	NDA011977
September 2, 1959	DECADRON	dexamethasone sodium phosphate	MERCK	NDA011984
August 26, 1959	DECADRON	dexamethasone sodium phosphate	MERCK	NDA011983
August 14, 1959	TEPANIL	diethylpropion hydrochloride	3M	NDA011673
August 10, 1959	METHOTREXATE PRESERVATIVE FREE	methotrexate sodium	HOSPIRA	NDA011719
August 6, 1959	TENUATE	diethylpropion hydrochloride	MPP PHARMA	NDA011722
August 5, 1959	HUMORSOL	demecarium bromide	MERCK	NDA011860
July 22, 1959	SALURON	hydroflumethiazide	SHIRE LLC	NDA011949
July 6, 1959	ORETIC	hydrochlorothiazide	ABBVIE	NDA011971
July 1, 1959	MARPLAN	isocarboxazid	LIFSA DRUGS	NDA011961
June 18, 1959	PROVERA	medroxyprogesterone acetate	PFIZER	NDA011839
June 12, 1959	BETAPRONE	propiolactone	FOREST LABS	NDA011657
June 10, 1959	ROBAXIN	methocarbamol	HIKMA	NDA011790
June 3, 1959	VISTARIL	hydroxyzine pamoate	PFIZER	NDA011795
May 27, 1959	DEPO-MEDROL	methylprednisolone acetate	PFIZER	NDA011757
May 18, 1959	SOLU-MEDROL	methylprednisolone sodium succinate	PHARMACIA AND UPJOHN	NDA011856
May 13, 1959	ANTURANE	sulfinpyrazone	NOVARTIS	NDA011556
May 7, 1959	XYLOCAINE 4% PRESERVATIVE FREE	lidocaine hydrochloride	FRESENIUS KABI USA	NDA010417
May 5, 1959	SERPASIL-ESIDRIX #2	hydrochlorothiazide, reserpine	NOVARTIS	NDA011878
May 4, 1959	IONAMIN	phentermine resin complex	UCB INC	NDA011613
April 16, 1959	PRESAMINE	imipramine hydrochloride	SANOFI AVENTIS US	NDA011836
April 16, 1959	STELAZINE	trifluoperazine hydrochloride	GLAXOSMITHKLINE	NDA011552
April 9, 1959	SOMA	carisoprodol	MYLAN SPECIALITY LP	NDA011792
April 2, 1959	OPANA	oxymorphone hydrochloride	ENDO PHARMS	NDA011707
March 12, 1959	ARISTOCORT	triamcinolone diacetate	FOSUN PHARMA	NDA011685
March 9, 1959	THIOTEPA	thiotepa	IMMUNEX	NDA011683
March 4, 1959	SODIUM PHOSPHATE P 32	sodium phosphate p-32	MALLINCKRODT	NDA011777
February 24, 1959	HYDRODIURIL	hydrochlorothiazide	MERCK	NDA011835
February 20, 1959	CHLOROMYCETIN	chloramphenicol sodium succinate	PARKEDALE	NDA050155
February 12, 1959	ESIDRIX	hydrochlorothiazide	NOVARTIS	NDA011793
February 9, 1959	IC-GREEN	indocyanine green	RENEW PHARMS	NDA011525
January 26, 1959	COMPAZINE	prochlorperazine	GLAXOSMITHKLINE	NDA011127
January 26, 1959	NEPTAZANE	methazolamide	LEDERLE	NDA011721
January 12, 1959	MESTINON	pyridostigmine bromide	BAUSCH	NDA011665