Locoid

NDA 18514, held by Bausch. Hydrocortisone Butyrate.

As of Nov 13, 2026, NDA 18514 (Locoid), held by Bausch, was first approved by FDA on Mar 31, 1982, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1982
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 31, 1982	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Locoid0.1% · cream;topical	Hydrocortisone Butyrate	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 30, 2014	Supplement 13Labeling · Standard review	Approved	Label Letter
Jan 8, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 5, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 12, 2005	Supplement 9Manufacturing · Standard review	Approved	Letter
May 22, 2002	Supplement 8Manufacturing · Standard review	Approved	Letter
Aug 30, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 14, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 25, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 24, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 20, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 31, 1982	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 18514
Drugs@FDA: Overview at FDA
Company: Bausch Health

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