Penecort

ANDA 88214, held by Allergan Herbert. Hydrocortisone.

As of Nov 14, 2026, ANDA 88214 (Penecort), held by Allergan Herbert, was first approved by FDA on Jun 6, 1984, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 6, 1984
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 6, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Penecort1% · solution;topical	Hydrocortisone	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


May 21, 1999	Supplement 8Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 7Manufacturing	Approved	None posted
Apr 7, 1998	Supplement 6Manufacturing	Approved	None posted
Feb 19, 1986	Supplement 4Manufacturing	Approved	None posted
Feb 19, 1986	Supplement 5Manufacturing	Approved	None posted
Mar 6, 1985	Supplement 1Manufacturing	Approved	None posted
Jun 6, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88214
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