Locoid

NDA 19116, held by Bausch. Hydrocortisone Butyrate.

As of Nov 13, 2026, NDA 19116 (Locoid), held by Bausch, was first approved by FDA on Feb 25, 1987, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1987
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 25, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 30, 2014	Supplement 9Labeling · Standard review	Approved	Label Letter
May 3, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
May 9, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 30, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 25, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 25, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19116
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