NDA 19101, held by Hikma. Fentanyl Citrate.
As of Nov 13, 2026, NDA 19101 (Fentanyl Citrate), held by Hikma, was first approved by FDA on Jul 11, 1984, with 34 approved supplements and 0 published complete response letters.
Fentanyl Citrate Injection is indicated for: analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. use as a narcotic analgesic supplement in general or regional anesthesia. administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fentanyl CitrateEQ 0.05MG BASE/ML · injectable;injection | Fentanyl Citrate | RxReference drug |
| Fentanyl CitrateEQ 0.025MG BASE/0.5ML · injectable;injection | Fentanyl Citrate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2025 | Supplement 74Labeling · Standard review | Approved | |
| Sep 25, 2025 | Supplement 72Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 65Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 63Labeling · Standard review | Approved | |
| Mar 3, 2023 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jan 20, 2023 | Supplement 60Manufacturing | Approved | |
| Oct 8, 2019 | Supplement 51Labeling · Standard review | Approved | |
| Jan 24, 2019 | Supplement 47Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 45Labeling · Standard review | Approved | |
| May 26, 2016 | Supplement 44Manufacturing | Approved | None posted |
| Feb 12, 2016 | Supplement 43Manufacturing | Approved | None posted |
| Nov 9, 2015 | Supplement 42Manufacturing | Approved | None posted |
| Jan 20, 2015 | Supplement 41Manufacturing | Approved | None posted |
| May 21, 2014 | Supplement 40Manufacturing | Approved | None posted |
| Mar 20, 2014 | Supplement 39Manufacturing | Approved | None posted |
| Feb 6, 2013 | Supplement 37Labeling | Approved | None posted |
| Feb 13, 2012 | Supplement 33Labeling | Approved | None posted |
| Feb 25, 2010 | Supplement 31Labeling | Approved | None posted |
| Aug 28, 2001 | Supplement 20Manufacturing | Approved | None posted |
| Jun 29, 2001 | Supplement 19Manufacturing | Approved | None posted |
| May 20, 1999 | Supplement 18Manufacturing | Approved | None posted |
| Nov 2, 1998 | Supplement 17Manufacturing | Approved | None posted |
| Aug 15, 1996 | Supplement 16Manufacturing | Approved | None posted |
| Mar 25, 1994 | Supplement 15Labeling | Approved | None posted |
| Jun 25, 1992 | Supplement 11Manufacturing | Approved | None posted |
| Aug 7, 1991 | Supplement 13Labeling | Approved | None posted |
| Aug 7, 1991 | Supplement 12Manufacturing | Approved | None posted |
| May 1, 1991 | Supplement 14Labeling | Approved | None posted |
| Jan 11, 1990 | Supplement 10Labeling | Approved | None posted |
| Nov 16, 1989 | Supplement 9Labeling | Approved | None posted |
| Nov 19, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Nov 5, 1985 | Supplement 2Manufacturing | Approved | None posted |
| Nov 5, 1985 | Supplement 1Manufacturing | Approved | None posted |
| Jan 30, 1985 | Supplement 4Manufacturing | Approved | None posted |
| Jul 11, 1984 | 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
