Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 70069, held by Cosette Pharms Nc. Betamethasone Valerate.
As of Nov 15, 2026, ANDA 70069 (Beta-Val), held by Cosette Pharms Nc, was first approved by FDA on Dec 19, 1985, with 8 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 |
|---|---|---|---|
| Dec 19, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Beta-ValEQ 0.1% BASE · ointment;topical | Betamethasone Valerate | Rx |
| Aug 30, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Jun 13, 1996 | Supplement 8Manufacturing | Approved | None posted |
| Aug 31, 1993 | Supplement 7Manufacturing | Approved | None posted |
| Oct 13, 1992 | Supplement 6Manufacturing | Approved | None posted |
| Jun 25, 1990 | Supplement 5Manufacturing | Approved | None posted |
| Jul 18, 1989 | Supplement 3Manufacturing | Approved | None posted |
| Jul 14, 1988 | Supplement 2Labeling | Approved | None posted |
| Feb 14, 1986 | Supplement 1Manufacturing | Approved | None posted |
| Dec 19, 1985 | 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
