ANDA 74413, held by Hikma. Sufentanil Citrate.
As of Nov 15, 2026, ANDA 74413 (Sufentanil Citrate), held by Hikma, was first approved by FDA on Dec 15, 1995, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sufentanil CitrateEQ 0.05MG BASE/ML · injectable;injection | Sufentanil Citrate | Discontinued |
| Jan 22, 2024 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jan 22, 2024 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jan 19, 2024 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 22, 2004 | Supplement 15Labeling | Approved | None posted |
| Mar 27, 2000 | Supplement 12Manufacturing | Approved | None posted |
| May 7, 1998 | Supplement 9Labeling | Approved | None posted |
| Apr 10, 1998 | Supplement 11Manufacturing | Approved | None posted |
| Apr 10, 1998 | Supplement 10Manufacturing | Approved | None posted |
| May 2, 1997 | Supplement 7Labeling | Approved | None posted |
| May 2, 1997 | Supplement 6Manufacturing | Approved | None posted |
| May 2, 1997 | Supplement 5Manufacturing | Approved | None posted |
| May 2, 1997 | Supplement 4Manufacturing | Approved | None posted |
| Jan 31, 1997 | Supplement 8Labeling | Approved | None posted |
| Sep 6, 1996 | Supplement 3Labeling | Approved | None posted |
| Jul 17, 1996 | Supplement 1Manufacturing | Approved | None posted |
| May 1, 1996 | Supplement 2Labeling | Approved | None posted |
| Dec 15, 1995 | 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
