FDA Approves Manufacturing Supplements for Isoniazid (ANDA080132)

The U.S. Food and Drug Administration has approved three manufacturing (CMC) supplement submissions—numbers 13, 15 and 18—associated with the ANDA080132 application for Isoniazid. All three supplements received approval status (AP) on dates ranging from March 4, 1982 to January 9, 1985. The ANDA lists two oral tablet products under the brand name ISONIAZID, identified by product numbers 003 and 004. Product 003 is a 50 mg tablet and product 004 is a 100 mg tablet. Both entries are marked as discontinued in the FDA database. The sponsor for this application is Purepac Pharm, which submitted the manufacturing supplements to maintain or modify the CMC aspects of the generic Isoniazid products.