APPLICATION
ANDA079187
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-27
LATEST ACTION
2025-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMDiscontinued
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
Approval history
2025-03-17Labeling · Supplement 7 · standardAP
2024-05-30Labeling · Supplement 5 · standardAP
2024-05-30Labeling · Supplement 6 · standardAP
2020-06-04Labeling · Supplement 4 · standardAP
2015-12-01Labeling · Supplement 2 · standardAP
2012-10-17Labeling · Supplement 1 · standardAP
2010-05-27OriginalAP
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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