Penecort

ANDA 88216, held by Allergan Herbert. Hydrocortisone.

As of Nov 13, 2026, ANDA 88216 (Penecort), held by Allergan Herbert, was first approved by FDA on Jun 6, 1984, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 6, 1984
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
Jun 6, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Penecort1% · cream;topical	Hydrocortisone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Dec 9, 1998	Supplement 7Manufacturing	Approved	None posted
Apr 7, 1998	Supplement 5Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 6Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 4Manufacturing	Approved	None posted
Mar 6, 1985	Supplement 1Manufacturing	Approved	None posted
Jun 6, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88216
Drugs@FDA: Overview at FDA
Company: Allergan Herbert

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