APPLICATION
ANDA077013
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-23
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
Approval history
2025-02-18Labeling · Supplement 6 · standardAP
2024-06-18Labeling · Supplement 5 · standardAP
2021-08-18Labeling · Supplement 4 · standardAP
2020-06-04Labeling · Supplement 3 · standardAP
2007-12-28Manufacturing (CMC) · Supplement 1AP
2007-12-28Labeling · 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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