ANDA 74171, held by Teva Pharms. Hydrocortisone.
As of Nov 14, 2026, ANDA 74171 (Hydrocortisone), held by Teva Pharms, was first approved by FDA on May 27, 1994, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 1994 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone100MG/60ML ยท enema;rectal | Hydrocortisone | Discontinued |
| Jun 17, 2008 | Supplement 23Labeling | Approved | None posted |
| Jul 9, 2002 | Supplement 15Manufacturing | Approved | None posted |
| Jan 23, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Jan 4, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Jan 4, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Feb 26, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Feb 15, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Feb 15, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Jun 25, 1998 | Supplement 3Manufacturing | Approved | None posted |
| May 31, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Nov 20, 1995 | Supplement 1Manufacturing | Approved | None posted |
| May 27, 1994 | 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
