APPLICATION
ANDA077751
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-30
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
Approval history
2025-02-18Labeling · Supplement 22 · standardAP
2016-11-08Labeling · Supplement 13 · standardAP
2015-09-16Labeling · Supplement 11 · standardAP
2015-09-16Labeling · Supplement 10 · standardAP
2012-03-26Labeling · Supplement 5AP
2011-07-25Labeling · Supplement 2AP
2008-04-30OriginalAP
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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