APPLICATION
ANDA209397
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-26
LATEST ACTION
2024-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FLUVASTATIN SODIUMPrescription
FLUVASTATIN SODIUM EQ 80MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-07-11Labeling · Supplement 3 · standardAP
2021-04-26UNKNOWN · 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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