Cloderm

NDA 17765, held by Legacy. Clocortolone Pivalate.

As of Nov 13, 2026, NDA 17765 (Cloderm), held by Legacy, was first approved by FDA on Aug 22, 1977, with 24 approved supplements and 0 published complete response letters.

First approved: Aug 22, 1977
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Aug 22, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cloderm0.1% · cream;topical	Clocortolone Pivalate	RxReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 21, 2009	Supplement 26Manufacturing	Approved	None posted
Feb 29, 2008	Supplement 25Manufacturing	Approved	None posted
Dec 10, 2003	Supplement 24Manufacturing · Standard review	Approved	Label Letter
Mar 14, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 11, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 27, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 15, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 12, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 27, 1989	Supplement 18Manufacturing · Standard review	Approved	None posted
May 17, 1988	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 7, 1986	Supplement 16Manufacturing · Standard review	Approved	None posted
May 31, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 3, 1983	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 1, 1983	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 2, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 31, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 14, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 24, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 24, 1980	Supplement 6Labeling	Approved	None posted
May 8, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 22, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 9, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 28, 1979	Supplement 2Labeling	Approved	None posted
Oct 19, 1977	Supplement 1Labeling	Approved	None posted
Aug 22, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17765
Drugs@FDA: Overview at FDA
Company: LEGACY

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