Westcort

NDA 18726, held by Sun Pharm Inds Inc. Hydrocortisone Valerate.

As of Nov 14, 2026, NDA 18726 (Westcort), held by Sun Pharm Inds Inc, was first approved by FDA on Aug 8, 1983, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 8, 1983
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

Date	Submission	Status	Documents
Aug 8, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Westcort0.2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Hydrocortisone Valerate	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Sep 3, 2002	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 3, 2002	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 22, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 3, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 21, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 27, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 8, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18726
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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