Ala-Cort

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 80706, held by Crown Labs. Hydrocortisone.

As of Nov 13, 2026, ANDA 80706 (Ala-Cort), held by Crown Labs, was first approved by FDA on Mar 9, 1973, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1973
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 9, 1973	Original application	Approved	None posted

Products

2 strengths and forms


Ala-Cort1% · cream;topical	Hydrocortisone	Rx
Ala-Cort2.5% · cream;topical	Hydrocortisone	Rx

All 7 submissions, including labeling and manufacturing supplements


Sep 22, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Jan 28, 1997	Supplement 8Labeling	Approved	None posted
May 22, 1992	Supplement 7Labeling	Approved	None posted
Jul 10, 1985	Supplement 5Manufacturing	Approved	None posted
Jul 10, 1985	Supplement 6Manufacturing	Approved	None posted
May 12, 1982	Supplement 2Manufacturing	Approved	None posted
Mar 9, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80706
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