APPLICATION
ANDA090595
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-11
LATEST ACTION
2020-09-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLUVASTATIN SODIUMPrescription
FLUVASTATIN SODIUM EQ 40MG BASE · CAPSULE · ORAL
FLUVASTATIN SODIUMPrescription
FLUVASTATIN SODIUM EQ 20MG BASE · CAPSULE · ORAL
Approval history
2020-09-25Labeling · Supplement 7 · standardAP
2020-09-15Labeling · Supplement 3 · standardAP
2013-03-26Labeling · Supplement 2 · standardAP
2012-04-11OriginalAP
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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