ANDA 74884, held by Genus Lifesciences. Clemastine Fumarate.
As of Nov 15, 2026, ANDA 74884 (Clemastine Fumarate), held by Genus Lifesciences, was first approved by FDA on Dec 17, 1997, with 2 approved supplements and 0 published complete response letters.
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 fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clemastine FumarateEQ 0.5MG BASE/5ML · syrup;oral | Clemastine Fumarate | Rx |
| May 31, 2002 | Supplement 2Labeling | Approved | None posted |
| May 31, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Dec 17, 1997 | Original application | Approved | None posted |
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
