Cogentin

NDA 9193, held by Merck. Benztropine Mesylate.

As of Nov 14, 2026, NDA 9193 (Cogentin), held by Merck, was first approved by FDA on Mar 5, 1954, with 27 approved supplements and 0 published complete response letters.

First approved: Mar 5, 1954
Review: Priority
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Mar 5, 1954	Original applicationNew molecular entity · Priority review	Approved	Letter

Products

3 strengths and forms


Cogentin2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Benztropine Mesylate	DiscontinuedReference drug
Cogentin1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Benztropine Mesylate	DiscontinuedReference drug
Cogentin0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Benztropine Mesylate	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 39Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 38Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 33Labeling	Approved	None posted
Mar 13, 2009	Supplement 24Labeling	Approved	None posted
Mar 13, 2009	Supplement 19Labeling	Approved	None posted
Mar 13, 2009	Supplement 15Labeling	Approved	None posted
May 22, 2001	Supplement 37Labeling · Standard review	Approved	Letter
Sep 26, 1996	Supplement 34Labeling	Approved	None posted
Apr 15, 1996	Supplement 36Manufacturing · Priority review	Approved	None posted
Jun 1, 1994	Supplement 35Manufacturing · Priority review	Approved	None posted
Apr 8, 1988	Supplement 32Manufacturing · Priority review	Approved	None posted
Jan 20, 1988	Supplement 31Manufacturing · Priority review	Approved	None posted
Aug 25, 1986	Supplement 30Manufacturing · Priority review	Approved	None posted
Jan 14, 1986	Supplement 29Labeling	Approved	None posted
Sep 13, 1984	Supplement 28Manufacturing · Priority review	Approved	None posted
Aug 15, 1984	Supplement 27Manufacturing · Priority review	Approved	None posted
Sep 3, 1982	Supplement 26Manufacturing · Priority review	Approved	None posted
Sep 3, 1982	Supplement 25Manufacturing · Priority review	Approved	None posted
Jun 2, 1981	Supplement 23Manufacturing · Priority review	Approved	None posted
May 14, 1981	Supplement 22Manufacturing · Priority review	Approved	None posted
May 1, 1980	Supplement 18Manufacturing · Priority review	Approved	None posted
Oct 5, 1979	Supplement 21Labeling	Approved	None posted
Apr 19, 1979	Supplement 20Labeling	Approved	None posted
May 5, 1977	Supplement 16Labeling	Approved	None posted
Mar 1, 1977	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 15, 1975	Supplement 14Labeling	Approved	None posted
Jul 1, 1974	Supplement 10REMS · Priority review	Approved	None posted
Mar 5, 1954	Original applicationNew molecular entity · Priority review	Approved	Letter

Identifiers

Application: NDA 9193
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters