Fentanyl Citrate

NDA 19115, held by Hospira. Fentanyl Citrate.

As of Nov 14, 2026, NDA 19115 (Fentanyl Citrate), held by Hospira, was first approved by FDA on Jan 12, 1985, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 12, 1985
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 an opioid 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jan 12, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fentanyl CitrateEQ 0.05MG BASE/ML · injectable;injection	Fentanyl Citrate	Rx

All 20 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 48Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 42Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 30Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 19, 2005	Supplement 18Labeling	Approved	None posted
Oct 25, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 7, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 4, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 3, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 30, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 30, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 8, 1992	Supplement 9Labeling	Approved	None posted
Mar 10, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 18, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 18, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 9, 1990	Supplement 6Labeling	Approved	None posted
May 17, 1989	Supplement 4Labeling	Approved	None posted
Jan 12, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19115
Drugs@FDA: Overview at FDA
Company: Hospira

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