Hydrocortisone

ANDA 80344, held by Whiteworth Town Plsn. Hydrocortisone.

As of Nov 13, 2026, ANDA 80344 (Hydrocortisone), held by Whiteworth Town Plsn, was first approved by FDA on Jul 18, 1973, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 18, 1973
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
Jul 18, 1973	Original application	Approved	None posted

Products

2 strengths and forms


Hydrocortisone10MG · tablet;oral	Hydrocortisone	Discontinued
Hydrocortisone20MG · tablet;oral	Hydrocortisone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 29, 1985	Supplement 10Manufacturing	Approved	None posted
Jul 29, 1985	Supplement 11Manufacturing	Approved	None posted
Jul 29, 1985	Supplement 12Manufacturing	Approved	None posted
Jul 18, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80344
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