APPLICATION
ANDA207068
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-17
LATEST ACTION
2025-03-17
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
2025-03-17Labeling · Supplement 7 · standardAP
2025-03-17Labeling · Supplement 8 · standardAP
2023-03-13Labeling · Supplement 5 · standardAP
2021-03-05Labeling · Supplement 2 · standardAP
2016-11-17UNKNOWN · Original · standardAP
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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