Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 18861, held by Fougera. Betamethasone Valerate.
As of Nov 14, 2026, NDA 18861 (Betamethasone Valerate), held by Fougera, was first approved by FDA on Aug 31, 1983, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Betamethasone ValerateEQ 0.1% BASE · cream;topical | Betamethasone Valerate | RxReference drug |
| Dec 4, 1997 | Supplement 9Manufacturing | Approved | None posted |
| Dec 12, 1996 | Supplement 8Labeling | Approved | None posted |
| Mar 7, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Oct 20, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Oct 20, 1988 | Supplement 5Manufacturing | Approved | None posted |
| Sep 14, 1988 | Supplement 6Labeling | Approved | None posted |
| Sep 14, 1988 | Supplement 23Labeling | Approved | None posted |
| Apr 23, 1987 | Supplement 2Manufacturing | Approved | None posted |
| Apr 23, 1987 | Supplement 3Manufacturing | Approved | None posted |
| Aug 31, 1983 | 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
