Hydrocortisone

ANDA 80496, held by Whiteworth Town Plsn. Hydrocortisone.

As of Nov 13, 2026, ANDA 80496 (Hydrocortisone), held by Whiteworth Town Plsn, was first approved by FDA on May 18, 1973, with 1 approved supplement and 0 published complete response letters.

First approved: May 18, 1973
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 18, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone1% · cream;topical	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 19, 1984	Supplement 5Manufacturing	Approved	None posted
May 18, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80496
Drugs@FDA: Overview at FDA
Company: Whiteworth Town Plsn

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