FDA Approves Teva Hydrochlorothiazide 50 mg Tablet (ANDA 088923)

The U.S. Food and Drug Administration has approved application number ANDA088923 submitted by Teva. The approved product is an oral tablet containing 50 mg of hydrochlorothiazide, identified as product number 001. The product’s marketing status is listed as discontinued. The original submission (submission number 1) received approval on February 7, 1985. A supplemental labeling submission (submission number 3) was approved on September 12, 1988. No reference drug or reference standard was cited for this ANDA.