APPLICATION
ANDA202458
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-11
LATEST ACTION
2023-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
FLUVASTATIN SODIUMDiscontinued
FLUVASTATIN SODIUM EQ 80MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-07-20Labeling · Supplement 2 · standardAP
2023-07-20Labeling · Supplement 5 · standardAP
2015-09-11UNKNOWN · 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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