Promethazine Hydrochloride Tablets

Type of Posting: 
Revision Bulletin
Posting Date: 
23–Nov–2011
Official Date: 
01–Dec–2011
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Promethazine Hydrochloride Tablets monograph. The purpose for the revision is to add Dissolution Test 2 for a new generic product approved by the FDA.

The Promethazine Hydrochloride Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30. 

Should you have any questions, please contact Mary Waddell (301-816-8124 or msw@usp.org).