APPLICATION
ANDA076714
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-23
LATEST ACTION
2025-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
Approval history
2025-06-26Labeling · Supplement 14 · standardAP
2016-11-25Labeling · Supplement 9 · standardAP
2016-02-01Labeling · Supplement 8 · standardAP
2014-11-03Labeling · Supplement 7 · standardAP
2012-07-20Labeling · Supplement 6AP
2007-12-28Labeling · Supplement 1AP
2007-12-28Manufacturing (CMC) · Supplement 2AP
2006-10-23OriginalAP
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.
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