Halfan

NDA 20250, held by Glaxosmithkline. Halofantrine Hydrochloride.

As of Nov 13, 2026, NDA 20250 (Halfan), held by Glaxosmithkline, was first approved by FDA on Jul 24, 1992, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1992
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 24, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Halfan250MG · tablet;oral	Halofantrine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 1, 2002	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 1, 2002	Supplement 8Labeling · Standard review	Approved	Letter Label
Aug 6, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Aug 6, 1997	Supplement 6Labeling · Standard review	Approved	None posted
Sep 23, 1993	Supplement 5Manufacturing · Priority review	Approved	None posted
Feb 12, 1993	Supplement 3Labeling · Standard review	Approved	None posted
Dec 2, 1992	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 24, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20250
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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