Methyldopate Hydrochloride

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 20, 1962	AldometNDA 13401 · New active ingredient	Merck	31	Discontinued
Jun 3, 1986	Methyldopate HydrochlorideANDA 70652	Abraxis Pharm	1	Discontinued
Jul 1, 1986	Methyldopate HydrochlorideANDA 70291	Baxter Hlthcare	9	Discontinued
Jun 15, 1987	Methyldopate HydrochlorideANDA 70698	Hospira	18	Discontinued
Jun 15, 1987	Methyldopate HydrochlorideANDA 70699	Hospira	9	Discontinued
Dec 2, 1987	Methyldopate HydrochlorideANDA 71279	Am Regent	9	Discontinued
Dec 22, 1987	Methyldopate HydrochlorideANDA 71812	Marsam Pharms LLC	2	Discontinued
Nov 22, 1991	Methyldopate HydrochlorideANDA 72974	Teva Parenteral	2	Discontinued
—	Methyldopate HydrochlorideANDA 70691	Hospira	0	Discontinued
—	Methyldopate HydrochlorideANDA 70841	Smith And Nephew	0	Discontinued
—	Methyldopate HydrochlorideANDA 70849	Hospira	0	Discontinued
—	Methyldopate HclANDA 71024	Quad Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA