Fentanyl Citrate

ANDA 70637, held by Abbott. Fentanyl Citrate.

As of Nov 14, 2026, ANDA 70637 (Fentanyl Citrate), held by Abbott, was first approved by FDA on Apr 30, 1990, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 30, 1990
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 30, 1990	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Apr 8, 1992	Supplement 1Labeling	Approved	None posted
Apr 30, 1990	Original application	Approved	None posted

Identifiers

Application: ANDA 70637
Drugs@FDA: Overview at FDA
Company: Abbott

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