NDA 16932, held by Schering. Betamethasone Valerate.
As of Nov 14, 2026, NDA 16932 (Valisone), held by Schering, was first approved by FDA on Jan 10, 1973, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 10, 1973 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| ValisoneEQ 0.1% BASE · lotion;topical | Betamethasone Valerate | Discontinued |
| Jan 25, 1996 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1996 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1989 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 13, 1986 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1984 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1983 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 31, 1979 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1973 | Original applicationNew dosage form · Standard review | 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
