Halog

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 17556, held by Sun Pharm Inds Inc. Halcinonide.

As of Nov 13, 2026, NDA 17556 (Halog), held by Sun Pharm Inds Inc, was first approved by FDA on Nov 27, 1974, with 28 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1974
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE HALOG (Halcinonide Cream, USP) 0.1% 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 29 submissions below

Date	Submission	Status	Documents
Nov 27, 1974	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Halog0.1% · cream;topical	Halcinonide	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Apr 2, 2014	Supplement 41Manufacturing · Standard review	Approved	None posted
Jun 10, 2009	Supplement 38Manufacturing	Approved	Label Letter
Sep 29, 2004	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 29, 1990	Supplement 33Manufacturing · Standard review	Approved	None posted
Jun 27, 1989	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 23, 1989	Supplement 31Manufacturing · Standard review	Approved	None posted
Nov 3, 1987	Supplement 30Manufacturing · Standard review	Approved	None posted
May 27, 1986	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 22, 1986	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 30, 1985	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 28, 1985	Supplement 26Manufacturing · Standard review	Approved	None posted
May 24, 1984	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 26, 1982	Supplement 23Labeling	Approved	None posted
Mar 18, 1982	Supplement 24Manufacturing · Standard review	Approved	None posted
May 20, 1980	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 24, 1980	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 13, 1980	Supplement 19Labeling	Approved	None posted
Feb 2, 1979	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 10, 1979	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 7, 1978	Supplement 16Labeling	Approved	None posted
Jun 7, 1978	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 19, 1978	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 9, 1978	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 8, 1977	Supplement 8Labeling	Approved	None posted
Feb 9, 1976	Supplement 7Manufacturing · Standard review	Approved	None posted
May 7, 1975	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 4, 1975	Supplement 4Labeling	Approved	None posted
Nov 27, 1974	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17556
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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