ANDA 74917, held by Dr Reddys. Fentanyl Citrate.
As of Nov 14, 2026, ANDA 74917 (Fentanyl Citrate Preservative Free), held by Dr Reddys, was first approved by FDA on Feb 3, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fentanyl Citrate Preservative FreeEQ 0.05MG BASE/ML · injectable;injection | Fentanyl Citrate | Discontinued |
| Jan 12, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 12, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 8, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Feb 3, 1998 | Original application | Approved |
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
