Inversine

NDA 10251, held by Targacept. Mecamylamine Hydrochloride.

As of Nov 14, 2026, NDA 10251 (Inversine), held by Targacept, was first approved by FDA on Mar 1, 1956, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 1, 1956
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Mar 1, 1956	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Inversine2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Mecamylamine Hydrochloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Oct 18, 2002	Supplement 24Manufacturing · Priority review	Approved	Letter
Jan 24, 2002	Supplement 23Manufacturing · Priority review	Approved	None posted
Mar 20, 2001	Supplement 22Manufacturing · Priority review	Approved	None posted
Mar 31, 2000	Supplement 21Manufacturing · Priority review	Approved	None posted
Mar 31, 2000	Supplement 20Labeling · Standard review	Approved	None posted
May 31, 1996	Supplement 19Manufacturing · Priority review	Approved	None posted
Dec 8, 1994	Supplement 18Labeling · Standard review	Approved	None posted
Sep 26, 1994	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 6, 1988	Supplement 16Manufacturing · Priority review	Approved	None posted
Jun 22, 1988	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 4, 1985	Supplement 14Labeling	Approved	None posted
Sep 6, 1985	Supplement 13Labeling	Approved	None posted
Nov 14, 1980	Supplement 12Labeling	Approved	None posted
Apr 30, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
Sep 27, 1979	Supplement 10Labeling	Approved	None posted
Sep 1, 1976	Supplement 9Labeling	Approved	None posted
Mar 1, 1956	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10251
Drugs@FDA: Overview at FDA
Company: Targacept

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