APPLICATION
ANDA079011
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2024-09-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FLUVASTATIN SODIUMPrescription
FLUVASTATIN SODIUM EQ 80MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-09-24Labeling · Supplement 7 · standardAP
2023-02-02Labeling · Supplement 6 · standardAP
2023-02-02Labeling · Supplement 2 · standardAP
2016-01-27OriginalAP
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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