Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 19141, held by Fougera. Betamethasone Dipropionate.
As of Nov 13, 2026, NDA 19141 (Betamethasone Dipropionate), held by Fougera, was first approved by FDA on Sep 4, 1984, with 12 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 |
|---|---|---|---|
| Sep 4, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Betamethasone DipropionateEQ 0.05% BASE · ointment;topical | Betamethasone Dipropionate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 1996 | Supplement 12Manufacturing | Approved | None posted |
| Mar 7, 1996 | Supplement 14Manufacturing | Approved | None posted |
| Aug 17, 1995 | Supplement 13Labeling | Approved | None posted |
| Jul 16, 1992 | Supplement 11Manufacturing | Approved | None posted |
| Nov 1, 1988 | Supplement 8Manufacturing | Approved | None posted |
| Nov 1, 1988 | Supplement 9Manufacturing | Approved | None posted |
| Nov 1, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Oct 20, 1987 | Supplement 5Manufacturing | Approved | None posted |
| Jul 6, 1987 | Supplement 6Manufacturing | Approved | None posted |
| Apr 23, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Jun 27, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Mar 28, 1986 | Supplement 1Manufacturing | Approved | None posted |
| Sep 4, 1984 | 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
