ANDA 80473, held by Valeant Intl. Hydrocortisone.
As of Nov 13, 2026, ANDA 80473 (Hytone), held by Valeant Intl, was first approved by FDA on Sep 25, 1972, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 1972 | Original application | Approved | None posted |
| Hytone1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical | Hydrocortisone | DiscontinuedReference drug |
| Hytone2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical | Hydrocortisone | DiscontinuedReference drug |
| Mar 27, 2002 | Supplement 20Manufacturing | Approved | None posted |
| Mar 4, 1999 | Supplement 19Manufacturing | Approved | None posted |
| Jan 20, 1998 | Supplement 18Manufacturing | Approved | None posted |
| Nov 30, 1993 | Supplement 17Manufacturing | Approved | None posted |
| Jan 27, 1992 | Supplement 16Manufacturing | Approved | None posted |
| Jan 27, 1992 | Supplement 15Manufacturing | Approved | None posted |
| Nov 2, 1983 | Supplement 12Manufacturing | Approved | None posted |
| Jul 8, 1983 | Supplement 11Manufacturing | Approved | None posted |
| Jan 11, 1983 | Supplement 7Manufacturing | Approved | None posted |
| Nov 30, 1982 | Supplement 9Manufacturing | Approved | None posted |
| Nov 30, 1982 | Supplement 8Manufacturing | Approved | None posted |
| Sep 25, 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
