Halog

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 17823, held by Sun Pharm Inds Inc. Halcinonide.

As of Nov 13, 2026, NDA 17823 (Halog), held by Sun Pharm Inds Inc, was first approved by FDA on May 4, 1977, with 22 approved supplements and 0 published complete response letters.

First approved: May 4, 1977
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE HALOG SOLUTION (Halcinonide Topical Solution, 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 23 submissions below

Date	Submission	Status	Documents
May 4, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 23 submissions, including labeling and manufacturing supplements


Mar 18, 2020	Supplement 24Manufacturing	Approved	Label Letter
Sep 29, 2004	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 8, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 23, 1992	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 27, 1989	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 2, 1988	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 30, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 22, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 30, 1984	Supplement 16Manufacturing · Standard review	Approved	None posted
May 31, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 21, 1983	Supplement 14Labeling	Approved	None posted
Dec 30, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 12, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 20, 1980	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 18, 1980	Supplement 5Labeling	Approved	None posted
Feb 13, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 29, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 18, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 10, 1979	Supplement 6Manufacturing · Standard review	Approved	None posted
May 12, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 9, 1978	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
May 4, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17823
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