Fentanyl Citrate Preservative Free

ANDA 72786, held by Hospira. Fentanyl Citrate.

As of Nov 14, 2026, ANDA 72786 (Fentanyl Citrate Preservative Free), held by Hospira, was first approved by FDA on Sep 24, 1991, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 24, 1991
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 24, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fentanyl Citrate Preservative FreeEQ 0.05MG BASE/ML · injectable;injection	Fentanyl Citrate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jul 15, 2024	Supplement 45Labeling · Standard review	Approved	None posted
Jan 22, 2024	Supplement 42Labeling · Standard review	Approved	None posted
Jan 19, 2024	Supplement 40Labeling · Standard review	Approved	None posted
Jun 11, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jun 11, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jun 11, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Feb 14, 2001	Supplement 4Manufacturing	Approved	None posted
Dec 22, 1995	Supplement 3Manufacturing	Approved	None posted
Mar 16, 1994	Supplement 2Manufacturing	Approved	None posted
Sep 24, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 72786
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