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Revision Bulletin

Fexofenadine Hydrochloride Tablets

Posting Date: 29 September 2009; updated 26 February 2010
Official Date: 1 November 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 Fexofenadine Hydrochloride Tablets monograph by the inclusion of a new Dissolution Test 3 for a new generic version of Fexofenadine Hydrochloride Tablets recently approved by the Food and Drug Administration.

Fexofenadine Hydrochloride Tablets 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 Fexofenadine Hydrochloride Tablets Revision Bulletin  (157KB).