Fluocinolone Acetonide

ANDA 201764, held by Amneal. Fluocinolone Acetonide.

As of Nov 15, 2026, ANDA 201764 (Fluocinolone Acetonide), held by Amneal, was first approved by FDA on Oct 17, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 17, 2011
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
Oct 17, 2011	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluocinolone Acetonide0.01% · oil;topical	Fluocinolone Acetonide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 3, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Oct 17, 2011	Original application	Approved	Review

Identifiers

Application: ANDA 201764
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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