FDA Grants Approval for AdaRe Pharm’s Potassium Chloride Extended‑Release Tablets (ANDA 076368)

The U.S. Food and Drug Administration has approved application ANDA 076368 for potassium chloride extended‑release tablets. The approval covers two oral tablet products, each formulated for extended release and intended for prescription use. The sponsor of the application is AdaRe Pharm Inc., with manufacturing handled by Sun Pharmaceutical Industries, Inc. Both products are listed under the brand name Potassium Chloride (extended‑release) and contain the active ingredient potassium chloride at strengths of 10 mEq and 20 mEq per tablet. The original ANDA submission (submission 1) received approval on August 18, 2004, and a labeling supplement (submission 6) was approved on June 29, 2009. The approved products are identified by several NDC codes, including 63304‑987‑01, 63304‑987‑05, 63304‑987‑10, 63304‑076‑01, 63304‑076‑05, and 63304‑076‑10. Both tablets are classified as human prescription drugs and are marketed under the extended‑release dosage form for oral administration.