Clemastine Fumarate

ANDA 73458, held by Pld Acquisitions LLC. Clemastine Fumarate.

As of Nov 15, 2026, ANDA 73458 (Clemastine Fumarate), held by Pld Acquisitions LLC, was first approved by FDA on Oct 31, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1993
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 31, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clemastine Fumarate1.34MG · tablet;oral	Clemastine Fumarate	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Dec 16, 2002	Supplement 11Manufacturing	Approved	None posted
May 15, 2002	Supplement 10Manufacturing	Approved	None posted
Apr 15, 2002	Supplement 9Manufacturing	Approved	None posted
Aug 7, 2001	Supplement 8Manufacturing	Approved	None posted
Jan 2, 2001	Supplement 7Manufacturing	Approved	None posted
Jan 2, 2001	Supplement 6Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 5Manufacturing	Approved	None posted
May 5, 1999	Supplement 3Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 2Manufacturing	Approved	None posted
Aug 15, 1997	Supplement 1Manufacturing	Approved	None posted
Oct 31, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73458
Drugs@FDA: Overview at FDA
Company: PLD Acquisitions

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