Clemastine Fumarate

ANDA 74863, held by Wockhardt Bio AG. Clemastine Fumarate.

As of Nov 15, 2026, ANDA 74863 (Clemastine Fumarate), held by Wockhardt Bio AG, was first approved by FDA on Mar 13, 1998, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 13, 1998
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 13, 1998	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 2 submissions, including labeling and manufacturing supplements


Nov 18, 2002	Supplement 1Manufacturing	Approved	None posted
Mar 13, 1998	Original application	Approved	None posted

Identifiers

Application: ANDA 74863
Drugs@FDA: Overview at FDA
Company: Wockhardt Bio AG

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