ANDA 80472, held by Valeant Intl. Hydrocortisone.
As of Nov 13, 2026, ANDA 80472 (Hytone), held by Valeant Intl, was first approved by FDA on Sep 27, 1972, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 1972 | Original application | Approved | None posted |
| Hytone1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Hydrocortisone | DiscontinuedReference drug |
| Hytone2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Hydrocortisone | DiscontinuedReference drug |
| Mar 27, 2002 | Supplement 30Manufacturing | Approved | None posted |
| Jan 27, 1992 | Supplement 28Manufacturing | Approved | None posted |
| Jan 27, 1992 | Supplement 27Manufacturing | Approved | None posted |
| Mar 15, 1985 | Supplement 25Manufacturing | Approved | None posted |
| Nov 15, 1983 | Supplement 21Manufacturing | Approved | None posted |
| Nov 15, 1983 | Supplement 20Manufacturing | Approved | None posted |
| Jul 8, 1983 | Supplement 18Manufacturing | Approved | None posted |
| Apr 8, 1982 | Supplement 16Manufacturing | Approved | None posted |
| Apr 8, 1982 | Supplement 15Manufacturing | Approved | None posted |
| Apr 8, 1982 | Supplement 6Manufacturing | Approved | None posted |
| Feb 26, 1982 | Supplement 17Manufacturing | Approved | None posted |
| Sep 27, 1972 | 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
