ANDA 88138, held by Pharmobedient. Hydrocortisone.
As of Nov 14, 2026, ANDA 88138 (Hydrocortisone In Absorbase), held by Pharmobedient, was first approved by FDA on Sep 6, 1985, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone In Absorbase1% ยท ointment;topical | Hydrocortisone | Rx |
| Jan 7, 1991 | Supplement 7Labeling | Approved | None posted |
| Sep 5, 1986 | Supplement 1Manufacturing | Approved | None posted |
| Sep 5, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Sep 6, 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
