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# ANI Pharma Gains ANDA OK for Potassium Citrate
- URL: https://www.fdaweb.com/ani-pharma-gains-anda-ok-for-potassium-citrate/
- Published: 2020-01-16T12:00:00.000Z
- Updated: 2026-09-14T15:58:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145868

FDA has approved an ANI Pharmaceuticals ANDA for potassium citrate extended-release tablets USP, 10 mEq and 15 mEq, indicated for managing renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. U.S. annual sales for the product are about $75 million, according to the company.