Propantheline Bromide

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Apr 2, 1953	Pro-BanthineNDA 8732 · New molecular entity	Shire	11	Discontinued
Sep 9, 1974	Propantheline BromideANDA 80927	Hikma	13	Discontinued
Jan 15, 1975	Propantheline BromideANDA 83029	Watson Labs	1	Discontinued
Aug 4, 1976	Propantheline BromideANDA 80977	Pvt Form	0	Discontinued
Oct 25, 1993	Propantheline BromideANDA 88377	Par Pharm	3	Discontinued
—	Propantheline BromideANDA 80928	Sandoz	5	Discontinued
—	Propantheline BromideANDA 83151	Watson Labs	0	Discontinued
—	Propantheline BromideANDA 83706	Mylan	0	Discontinued
—	Propantheline BromideANDA 84428	Tablicaps	0	Discontinued
—	Propantheline BromideANDA 84541	Impax Labs	0	Discontinued
—	Propantheline BromideANDA 85780	Heather	0	Discontinued
—	Propantheline BromideANDA 87663	Ascot	1	Discontinued
—	Pro-BanthineNDA 8843	Gd Searle LLC	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