Clemastine Fumarate

ANDA 73399, held by Genus. Clemastine Fumarate.

As of Nov 15, 2026, ANDA 73399 (Clemastine Fumarate), held by Genus, was first approved by FDA on Jun 30, 1994, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1994
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION ). It should be noted that clemastine is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jun 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 18 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 17Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 16Manufacturing	Approved	None posted
Dec 9, 1999	Supplement 15Manufacturing	Approved	None posted
Apr 15, 1998	Supplement 12Manufacturing	Approved	None posted
Oct 30, 1997	Supplement 14Manufacturing	Approved	None posted
Oct 30, 1997	Supplement 11Manufacturing	Approved	None posted
May 5, 1997	Supplement 13Manufacturing	Approved	None posted
Oct 2, 1995	Supplement 10Manufacturing	Approved	None posted
Oct 2, 1995	Supplement 9Manufacturing	Approved	None posted
Oct 2, 1995	Supplement 8Manufacturing	Approved	None posted
Oct 2, 1995	Supplement 7Manufacturing	Approved	None posted
Oct 2, 1995	Supplement 6Manufacturing	Approved	None posted
Oct 2, 1995	Supplement 5Manufacturing	Approved	None posted
Jun 29, 1995	Supplement 4Manufacturing	Approved	None posted
Jun 29, 1995	Supplement 3Manufacturing	Approved	None posted
May 4, 1995	Supplement 2Manufacturing	Approved	None posted
May 4, 1995	Supplement 1Manufacturing	Approved	None posted
Jun 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 73399
Drugs@FDA: Overview at FDA
Company: Genus Lifesciences

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