Halog-E

NDA 18234, held by Sun Pharm Inds Inc. Halcinonide.

As of Nov 14, 2026, NDA 18234 (Halog-E), held by Sun Pharm Inds Inc, was first approved by FDA on Jan 24, 1980, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1980
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 24, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Halog-E0.1% · cream;topical	Halcinonide	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Sep 29, 2004	Supplement 20Labeling · Standard review	Approved	Label Letter
Jul 17, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 27, 1989	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 6, 1988	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 24, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 26, 1986	Supplement 16Manufacturing · Standard review	Approved	None posted
May 27, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 11, 1986	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 29, 1985	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 28, 1985	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 16, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 3, 1984	Supplement 9Labeling	Approved	None posted
Aug 19, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 5, 1983	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 13, 1982	Supplement 6Labeling	Approved	None posted
Jun 22, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 21, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 20, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 15, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 3, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 24, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18234
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