ANDA 75703, held by Apotex Inc. Clemastine Fumarate.
As of Nov 15, 2026, ANDA 75703 (Clemastine Fumarate), held by Apotex Inc, was first approved by FDA on Nov 27, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clemastine FumarateEQ 0.5MG BASE/5ML ยท syrup;oral | Clemastine Fumarate | Discontinued |
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
