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Revision Bulletin

Ondansetron Tablets

Posting Date: 30 October 2009; updated 26 February 2010
Official Date: 1 December 2009
Expert Committee: Biopharmaceutics


In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Biopharmaceutics Expert Committee has revised the Ondansetron Tablets monograph to include a Dissolution Test 2 due to FDA’s approval of a generic product with different Tolerances; and a Dissolution Test 3 due to the U.S. Food and Drug Administration’s approval of another generic product with different dissolution conditions.

The Ondansetron Revision Bulletin supersedes the currently official monograph and will be incorporated into the First Supplement to the USP 33-NF 28 Reissue.

Should you have any questions, please contact Margareth Marques, Ph.D., (301–816–8106 or .

Download the Ondansetron Tablets Revision Bulletin  (150KB)