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As of Nov 14, 2026, ANDA 212086 (Fentanyl Citrate), held by Fresenius Kabi USA, was first approved by FDA on Sep 1, 2020, with 1 approved supplement and 0 published complete response letters.
First approved: Sep 1, 2020
Review: Standard
Supplements approved: 1
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.
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
