The U.S. Food and Drug Administration has granted approval for the Abbreviated New Drug Application (ANDA) 077491 submitted by Amici Pharma, Inc. for generic Pravastatin Sodium tablets.
The approved product is an oral tablet available in six strengths – 10 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg – each marketed as a prescription medication.
FDA submission records show approval of labeling (submission numbers 9 and 5) with status dates June 6 2026 and September 9 2019, and approval of a manufacturing (CMC) submission (number 7) dated August 6 2026.
The product is listed under the human prescription drug category with NDC codes ranging from 69292‑101‑10 to 69292‑104‑90.
規制動向2026年9月10日•1分で読めます
FDA Approves Amici Pharma’s Generic Pravastatin Sodium Tablets (ANDA 077491)
The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.
PharmaCountryチームがまとめました · 出典： FDA.gov
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