APPLICATION
ANDA077793
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-15
LATEST ACTION
2025-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
Approval history
2025-02-24Labeling · Supplement 18 · standardAP
2023-03-20Labeling · Supplement 16 · standardAP
2021-02-11Labeling · Supplement 13 · standardAP
2016-11-20Labeling · Supplement 7 · standardAP
2015-04-15Labeling · Supplement 1AP
2015-04-15Labeling · Supplement 6 · standardAP
2013-02-05Labeling · Supplement 5 · standardAP
2012-05-03Labeling · Supplement 4AP
2011-09-27Labeling · Supplement 3AP
2008-01-15OriginalAP
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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