Clemastine Fumarate

ANDA 74075, held by Actavis Mid Atlantic. Clemastine Fumarate.

As of Nov 15, 2026, ANDA 74075 (Clemastine Fumarate), held by Actavis Mid Atlantic, was first approved by FDA on Oct 31, 1993, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1993
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 31, 1993	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 7 submissions, including labeling and manufacturing supplements


Dec 4, 2000	Supplement 7Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 8Manufacturing	Approved	None posted
Mar 27, 2000	Supplement 4Manufacturing	Approved	None posted
Mar 27, 2000	Supplement 5Labeling	Approved	None posted
Mar 27, 2000	Supplement 6Manufacturing	Approved	None posted
Feb 8, 1994	Supplement 1Labeling	Approved	None posted
Oct 31, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74075
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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