Cyclocort

NDA 19729, held by Astellas. Amcinonide.

As of Nov 14, 2026, NDA 19729 (Cyclocort), held by Astellas, was first approved by FDA on Jun 13, 1988, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1988
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 13, 1988	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyclocort0.1% · lotion;topical	Amcinonide	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Jan 19, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 23, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 23, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 22, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 2, 1989	Supplement 3Labeling	Approved	None posted
Sep 30, 1988	Supplement 2Labeling	Approved	None posted
Jul 13, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 13, 1988	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 19729
Drugs@FDA: Overview at FDA
Company: Astellas Pharma

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