Ala-Cort

ANDA 83201, held by Crown Labs. Hydrocortisone.

As of Nov 13, 2026, ANDA 83201 (Ala-Cort), held by Crown Labs, was first approved by FDA on Feb 28, 1973, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 28, 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
Feb 28, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ala-Cort1% · lotion;topical	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 10, 1996	Supplement 2Labeling	Approved	None posted
Feb 28, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83201
Drugs@FDA: Overview at FDA
Company: Crown Laboratories

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