Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA.
🏛 Food and Drug Administration (FDA)FDA-2026-P-5994
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
Supporting & Related MaterialMay 28, 2026
Attachment 1 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations