ANDA 73283, held by Genus. Clemastine Fumarate.
As of Nov 15, 2026, ANDA 73283 (Clemastine Fumarate), held by Genus, was first approved by FDA on Jan 31, 1992, with 28 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clemastine Fumarate2.68MG · tablet;oral | Clemastine Fumarate | Rx |
| Aug 30, 2001 | Supplement 28Manufacturing | Approved | None posted |
| Aug 2, 2000 | Supplement 26Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 27Manufacturing | Approved | None posted |
| Jul 1, 1998 | Supplement 25Manufacturing | Approved | None posted |
| Dec 13, 1996 | Supplement 23Manufacturing | Approved | None posted |
| Nov 26, 1996 | Supplement 24Manufacturing | Approved | None posted |
| Jul 1, 1996 | Supplement 22Manufacturing | Approved | None posted |
| Jan 25, 1996 | Supplement 21Manufacturing | Approved | None posted |
| Jan 25, 1996 | Supplement 20Manufacturing | Approved | None posted |
| Jan 25, 1996 | Supplement 19Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 18Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 17Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 16Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 15Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 14Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 13Manufacturing | Approved | None posted |
| Feb 10, 1994 | Supplement 9Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 12Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 11Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 10Manufacturing | Approved | None posted |
| Aug 31, 1993 | Supplement 8Manufacturing | Approved | None posted |
| Aug 31, 1993 | Supplement 7Manufacturing | Approved | None posted |
| May 25, 1993 | Supplement 6Manufacturing | Approved | None posted |
| May 25, 1993 | Supplement 5Manufacturing | Approved | None posted |
| May 25, 1993 | Supplement 4Manufacturing | Approved | None posted |
| May 7, 1993 | Supplement 2Manufacturing | Approved | None posted |
| Apr 1, 1993 | Supplement 3Manufacturing | Approved | None posted |
| Mar 8, 1993 | Supplement 1Manufacturing | Approved | None posted |
| Jan 31, 1992 | 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
