APPLICATION
ANDA203367
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-02
LATEST ACTION
2025-03-18
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
2025-03-18Labeling · Supplement 9 · standardAP
2023-04-13Labeling · Supplement 7 · standardAP
2021-03-15Labeling · Supplement 5 · standardAP
2017-02-02UNKNOWN · OriginalAP
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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