APPLICATION
ANDA076341
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-23
LATEST ACTION
2025-02-18
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
2025-02-18Labeling · Supplement 31 · standardAP
2023-04-26Labeling · Supplement 26 · standardAP
2021-03-05Labeling · Supplement 25 · standardAP
2017-07-07Labeling · Supplement 19 · standardAP
2013-07-26Labeling · Supplement 15 · standardAP
2012-07-12Labeling · Supplement 13AP
2007-12-28Labeling · Supplement 2AP
2007-12-28Manufacturing (CMC) · Supplement 1AP
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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