Clemastine Fumarate

ANDA 73282, held by Ani Pharms. Clemastine Fumarate.

As of Nov 15, 2026, ANDA 73282 (Clemastine Fumarate), held by Ani Pharms, was first approved by FDA on Jan 31, 1992, with 30 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1992
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Jan 31, 1992	Original application	Approved	None posted

Products

2 strengths and forms


Clemastine Fumarate1.34MG · tablet;oral	Clemastine Fumarate	Discontinued
Clemastine Fumarate1.34MG · tablet;oral	Clemastine Fumarate	Discontinued

All 31 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 35Manufacturing	Approved	None posted
Aug 2, 2000	Supplement 33Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 34Manufacturing	Approved	None posted
Jul 1, 1998	Supplement 32Manufacturing	Approved	None posted
Dec 13, 1996	Supplement 30Manufacturing	Approved	None posted
Nov 26, 1996	Supplement 31Manufacturing	Approved	None posted
Jul 1, 1996	Supplement 29Manufacturing	Approved	None posted
Feb 27, 1996	Supplement 23Labeling	Approved	None posted
Jan 25, 1996	Supplement 26Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 25Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 24Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 22Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 21Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 20Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 19Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 18Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 17Manufacturing	Approved	None posted
Feb 10, 1994	Supplement 13Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 16Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 15Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 14Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 11Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 10Manufacturing	Approved	None posted
May 25, 1993	Supplement 8Manufacturing	Approved	None posted
May 25, 1993	Supplement 7Manufacturing	Approved	None posted
May 25, 1993	Supplement 6Manufacturing	Approved	None posted
May 7, 1993	Supplement 4Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 5Manufacturing	Approved	None posted
Mar 8, 1993	Supplement 1Manufacturing	Approved	None posted
Dec 3, 1992	Supplement 2Labeling	Approved	None posted
Jan 31, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73282
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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