APPLICATION
ANDA077917
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-08
LATEST ACTION
2025-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
Approval history
2025-03-17Labeling · Supplement 22 · standardAP
2022-10-13Labeling · Supplement 21 · standardAP
2021-02-01Labeling · Supplement 19 · standardAP
2017-07-11Labeling · Supplement 17 · standardAP
2014-11-03Manufacturing (CMC) · Supplement 16 · unknownAP
2013-04-18Labeling · Supplement 15 · standardAP
2008-06-16Labeling · Supplement 2AP
2008-01-08OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.