Fentanyl Citrate Preservative Free

ANDA 210762, held by Fresenius Kabi USA. Fentanyl Citrate.

As of Nov 14, 2026, ANDA 210762 (Fentanyl Citrate Preservative Free), held by Fresenius Kabi USA, was first approved by FDA on May 3, 2019, with 6 approved supplements and 0 published complete response letters.

First approved: May 3, 2019
Review: Standard
Supplements approved: 6
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 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
May 3, 2019	Original application	Approved	Letter

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Oct 1, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Oct 1, 2026	Supplement 11Labeling · Standard review	Approved	None posted
Apr 24, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Apr 24, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Apr 24, 2025	Supplement 8Labeling · Standard review	Approved	None posted
May 7, 2020	Supplement 1Labeling · Standard review	Approved	None posted
May 3, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 210762
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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