Ala-Scalp

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 83231, held by Legacy. Hydrocortisone.

As of Nov 13, 2026, ANDA 83231 (Ala-Scalp), held by Legacy, was first approved by FDA on Feb 28, 1973, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1973
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hydrocortisone Lotion is 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
Feb 28, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ala-Scalp2% · lotion;topical	Hydrocortisone	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Jan 22, 2015	Supplement 7Labeling	Approved	None posted
May 20, 1991	Supplement 5Labeling	Approved	None posted
Jun 7, 1990	Supplement 4Labeling	Approved	None posted
May 11, 1982	Supplement 1Manufacturing	Approved	None posted
May 11, 1982	Supplement 2Manufacturing	Approved	None posted
Mar 26, 1982	Supplement 3Manufacturing	Approved	None posted
Feb 28, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83231
Drugs@FDA: Overview at FDA
Company: LEGACY

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