Anzemet

NDA 20624, held by Validus Pharms. Dolasetron Mesylate.

As of Nov 14, 2026, NDA 20624 (Anzemet), held by Validus Pharms, was first approved by FDA on Sep 11, 1997, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 11, 1997
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 11, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

3 strengths and forms


Anzemet100MG/5ML (20MG/ML) · injectable;injection	Dolasetron Mesylate	DiscontinuedReference drug
Anzemet12.5MG/0.625ML (20MG/ML) · injectable;injection	Dolasetron Mesylate	DiscontinuedReference drug
Anzemet500MG/25ML (20MG/ML) · injectable;injection	Dolasetron Mesylate	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 25Labeling	Approved	Letter Label
Sep 20, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 16, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Sep 22, 2011	Supplement 22Labeling	Approved	Label Letter
Oct 6, 2009	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 24, 2007	Supplement 17Labeling · Standard review	Approved	Letter
May 30, 2007	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 1, 2005	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 18, 2003	Supplement 9Manufacturing · Standard review	Approved	Review Letter
Feb 13, 2003	Supplement 3Manufacturing · Standard review	Approved	Letter
May 24, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 22, 2002	Supplement 8Labeling · Standard review	Approved	Review Letter
Dec 11, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 26, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 26, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 25, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Oct 17, 1997	Supplement 1Labeling · Standard review	Approved	None posted
Sep 11, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20624
Drugs@FDA: Overview at FDA
Company: Validus Pharmaceuticals

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