FDA Approves ANDA 088119 for Isoniazid 300 mg Tablet

The U.S. Food and Drug Administration (FDA) has approved application number ANDA088119 for an oral tablet containing 300 mg of Isoniazid. The product, identified by brand name Isoniazid, is manufactured by Duramed Pharms Barr and is currently listed with a marketing status of "Discontinued". Product details: - Route: Oral - Dosage form: Tablet - Product number: 001 - Active ingredient: Isoniazid 300 MG - Reference drug: No - Reference standard: No Regulatory submission history includes multiple supplemental filings (SUPPL) and an original filing (ORIG). All submissions received an "AP" (Approved) status. Key dates include the original filing on 17 Mar 1983 and the most recent supplemental labeling submission on 12 May 1997. Submission classes covered labeling and manufacturing (CMC) aspects. The approval reflects compliance with FDA requirements for labeling and manufacturing, despite the product’s discontinued marketing status.