APPLICATION
ANDA077491
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-11
LATEST ACTION
2026-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
Approval history
2026-02-06Labeling · Supplement 9 · standardAP
2019-09-09Labeling · Supplement 5 · standardAP
2015-12-01Labeling · Supplement 3 · standardAP
2015-12-01Labeling · Supplement 4 · standardAP
2014-11-02Labeling · Supplement 2 · standardAP
2008-02-11OriginalAP
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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