APPLICATION
ANDA075551
TYPE
ANDA
ORIGINAL APPROVAL
2001-12-17
LATEST ACTION
2020-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOVASTATINPrescription
LOVASTATIN 20MG · TABLET · ORAL
LOVASTATINPrescription
LOVASTATIN 10MG · TABLET · ORAL
LOVASTATINPrescription
LOVASTATIN 40MG · TABLET · ORAL
Approval history
2020-09-25Labeling · Supplement 28 · standardAP
2020-09-25Labeling · Supplement 29 · standardAP
2014-11-02Labeling · Supplement 24 · standardAP
2013-01-29Labeling · Supplement 23 · standardAP
2012-05-02Labeling · Supplement 22AP
2009-04-14Labeling · Supplement 19AP
2007-10-05Labeling · Supplement 13AP
2006-03-13Labeling · Supplement 12AP
2006-03-02Labeling · Supplement 10AP
2005-08-18Labeling · Supplement 2AP
2005-08-18Labeling · Supplement 9AP
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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