Clemastine Fumarate

ANDA 73095, held by Teva Pharms. Clemastine Fumarate.

As of Nov 15, 2026, ANDA 73095 (Clemastine Fumarate), held by Teva Pharms, was first approved by FDA on Apr 21, 1992, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 21, 1992
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 21, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clemastine FumarateEQ 0.5MG BASE/5ML · syrup;oral	Clemastine Fumarate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 10Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 9Manufacturing	Approved	None posted
May 13, 1998	Supplement 8Manufacturing	Approved	None posted
May 31, 1996	Supplement 7Manufacturing	Approved	None posted
Aug 15, 1995	Supplement 5Labeling	Approved	None posted
Aug 15, 1995	Supplement 4Manufacturing	Approved	None posted
Aug 15, 1995	Supplement 3Manufacturing	Approved	None posted
Oct 20, 1994	Supplement 6Labeling	Approved	None posted
May 23, 1994	Supplement 2Manufacturing	Approved	None posted
Apr 21, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73095
Drugs@FDA: Overview at FDA
Company: Teva 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