FDA approves labeling supplement for Sun Pharma's generic rosuvastatin calcium tablets
The FDA cleared a labeling supplement covering four strengths of Sun Pharma's rosuvastatin calcium tablets, effective July 16, 2026.
Sun Pharma had a labeling update approved for its generic rosuvastatin calcium tablets during the period.
- Sun Pharma's rosuvastatin calcium tablets, an oral drug sold in strengths of 5mg, 10mg, 20mg, and 40mg base, received approval for a labeling supplement (submission number 22) under ANDA079169, with a standard review priority and a submission status date of 2026-07-16.1
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