Lidex

NDA 16909, held by Alvogen. Fluocinonide.

As of Nov 14, 2026, NDA 16909 (Lidex), held by Alvogen, was first approved by FDA on Sep 22, 1971, with 35 approved supplements and 0 published complete response letters.

First approved: Sep 22, 1971
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Sep 22, 1971	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lidex0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Fluocinonide	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Jun 8, 2016	Supplement 53Manufacturing · Standard review	Approved	Label
Dec 16, 2005	Supplement 49Manufacturing · Standard review	Approved	Letter
Sep 26, 2000	Supplement 47Manufacturing · Standard review	Approved	None posted
Jul 22, 1996	Supplement 46Manufacturing · Standard review	Approved	None posted
Nov 16, 1992	Supplement 45Manufacturing · Standard review	Approved	None posted
Apr 24, 1992	Supplement 44Manufacturing · Standard review	Approved	None posted
Mar 12, 1991	Supplement 43Labeling	Approved	None posted
Feb 13, 1990	Supplement 42Manufacturing · Standard review	Approved	None posted
Dec 6, 1989	Supplement 41Manufacturing · Standard review	Approved	None posted
Sep 26, 1989	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 10, 1989	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 29, 1984	Supplement 38Manufacturing · Standard review	Approved	None posted
May 16, 1984	Supplement 37Manufacturing · Standard review	Approved	None posted
Sep 7, 1983	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 21, 1983	Supplement 35Labeling	Approved	None posted
Nov 19, 1982	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 20, 1981	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 10, 1981	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 24, 1981	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 19, 1981	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 19, 1981	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 19, 1981	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 19, 1981	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 7, 1980	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 23, 1979	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 13, 1979	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 2, 1979	Supplement 20Labeling	Approved	None posted
Nov 30, 1978	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 29, 1978	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 7, 1978	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 5, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 11, 1978	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 14, 1977	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 4, 1977	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 11, 1977	Supplement 14Labeling	Approved	None posted
Sep 22, 1971	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16909
Drugs@FDA: Overview at FDA
Company: Alvogen

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