APPLICATION
ANDA076939
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-23
LATEST ACTION
2025-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
Approval history
2025-02-24Labeling · Supplement 19 · standardAP
2020-06-04Labeling · Supplement 18 · standardAP
2014-11-02Labeling · Supplement 12 · standardAP
2012-07-20Labeling · Supplement 9 · standardAP
2012-01-19Labeling · Supplement 7AP
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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