|
Information For:
|
Revision BulletinOndansetron Tablets
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 What's New
![]() USP recalled USP 33-NF 28 on Jan. 8, 2010. A reissue product will be available in April 2010.
PF 36(2), March-April 2010: IRAs and Errata (03/01/10) February Revision Bulletins (02/26/10) Protamine Monographs: Notice of Intent to Revise (02/26/10) New Draft Pending Standard for the month of February (02/26/10) PF 36(2), March-April 2010: Highlights (02/22/10) Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies (02/22/10) Performance of Equipment to Test Dissolution of Medications Further Assured (02/09/10) New Official Text (01/29/10) Related Resources |
||||||||||||||||||||||||||||
Copyright © 2010 The United States Pharmacopeial Convention
|
|||||||||||||||||||||||||||||