Type of Posting: Revision Bulletin
Posting Date: 30–Sep–2010; updated 15–Oct–2010*
Official Date: 01–Feb–2011
Expert Committee: Monographs—Small Molecules 4
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 (SM4) Expert Committee has revised the Zolpidem Tartrate Tablets monograph. The purpose for the revision is to include a Dissolution Test 2 for a generic product recently approved by FDA.
The Zolpidem Tartrate Tablets Revision Bulletin supersedes the currently official Zolpidem Tartrate Tablets monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 34–NF 29.
Should you have any questions, please contact Margareth Marques, Ph.D. (301-816-8106 or mrm@usp.org).
* Revised official date to 01 February 2011 to align with other monograph changes coming official 01 February 2011 in the Second Supplement to the USP 33–NF 28 Reissue.