Locoid Lipocream

NDA 20769, held by Precision Dermat. Hydrocortisone Butyrate.

As of Nov 13, 2026, NDA 20769 (Locoid Lipocream), held by Precision Dermat, was first approved by FDA on Sep 8, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 8, 1997
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


Oct 19, 2009	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 8, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Locoid Lipocream0.1% · cream;topical	Hydrocortisone Butyrate	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Oct 3, 2024	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 20, 2014	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 19, 2009	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 4, 2009	Supplement 12Manufacturing	Approved	None posted
Apr 21, 2006	Supplement 9Manufacturing	Approved	Letter
Aug 23, 2004	Supplement 3Manufacturing · Standard review	Approved	Letter
Mar 12, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 8, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20769
Drugs@FDA: Overview at FDA
Company: Precision Dermat

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