Locoid

NDA 22076, held by Bausch. Hydrocortisone Butyrate.

As of Nov 14, 2026, NDA 22076 (Locoid), held by Bausch, was first approved by FDA on May 18, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: May 18, 2007
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 18, 2007	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Locoid0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · lotion;topical	Hydrocortisone Butyrate	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Oct 18, 2023	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 30, 2014	Supplement 5Labeling · Standard review	Approved	Label Letter
Nov 19, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
May 18, 2007	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 22076
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