APPLICATION
ANDA076056
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-24
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 40MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 10MG · TABLET · ORAL
Approval history
2025-02-24Labeling · Supplement 25 · standardAP
2021-02-16Labeling · Supplement 21 · standardAP
2017-01-23Labeling · Supplement 16 · standardAP
2015-11-30Labeling · Supplement 14 · standardAP
2013-02-05Labeling · Supplement 13 · standardAP
2012-12-30Labeling · Supplement 12 · standardAP
2012-05-04Labeling · Supplement 11AP
2011-09-27Labeling · Supplement 10AP
2010-01-08Manufacturing (CMC) · Supplement 8AP
2007-10-05Labeling · Supplement 7AP
2007-03-16Labeling · Supplement 5AP
2006-09-27Labeling · Supplement 2AP
2006-04-24OriginalAP
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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