Halog

NDA 17824, held by Sun Pharm Inds Inc. Halcinonide.

As of Nov 13, 2026, NDA 17824 (Halog), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 15, 1977, with 23 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1977
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jun 15, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Halog0.1% · ointment;topical	Halcinonide	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Sep 29, 2004	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 29, 1990	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 27, 1989	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 3, 1987	Supplement 21Manufacturing · Standard review	Approved	None posted
May 27, 1986	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 29, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 24, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 13, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 12, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 2, 1982	Supplement 13Labeling	Approved	None posted
Feb 26, 1981	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 15, 1980	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 13, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 19, 1979	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 17, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 10, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 9, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
May 12, 1978	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 8, 1978	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 9, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 15, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17824
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