Tigan

Treats postoperative nausea and vomiting. NDA 17530, held by Ph Health. Trimethobenzamide Hydrochloride.

As of Nov 14, 2026, NDA 17530 (Tigan), held by Ph Health, was first approved by FDA on Jul 12, 1974, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 12, 1974
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indications Tigan is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 12, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tigan100MG/ML · injectable;injection	Trimethobenzamide Hydrochloride	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Apr 18, 2008	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 26, 2005	Supplement 23Manufacturing · Standard review	Approved	Letter Label
Aug 26, 2005	Supplement 22Manufacturing · Standard review	Approved	Letter Label
Aug 26, 2005	Supplement 21Manufacturing · Standard review	Approved	Letter Label
Jun 28, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 30, 2002	Supplement 18Labeling · Standard review	Approved	Review Label Letter
Feb 23, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 14, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 28, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 22, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 3, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 20, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 15, 1981	Supplement 8Labeling	Approved	None posted
Sep 25, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 18, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
May 12, 1975	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 12, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17530
Drugs@FDA: Overview at FDA
Company: PH Health

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