APPLICATION
ANDA075991
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-05
LATEST ACTION
2020-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOVASTATINPrescription
LOVASTATIN 40MG · TABLET · ORAL
LOVASTATINPrescription
LOVASTATIN 10MG · TABLET · ORAL
LOVASTATINPrescription
LOVASTATIN 20MG · TABLET · ORAL
Approval history
2020-09-25Labeling · Supplement 21 · standardAP
2017-08-04Labeling · Supplement 19 · standardAP
2014-12-01Labeling · Supplement 17 · standardAP
2013-04-29Labeling · Supplement 16 · standardAP
2012-10-12Labeling · Supplement 15 · standardAP
2010-05-03Labeling · Supplement 12AP
2009-10-22Labeling · Supplement 13AP
2006-03-02Labeling · Supplement 7AP
2004-06-30Labeling · Supplement 2AP
2002-06-05OriginalAP
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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