APPLICATION
ANDA075828
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 40MG · TABLET · ORAL
LOVASTATINPrescription
LOVASTATIN 10MG · TABLET · ORAL
Approval history
2020-09-25Labeling · Supplement 39 · standardAP
2017-08-04Labeling · Supplement 36 · standardAP
2014-11-02Labeling · Supplement 34 · standardAP
2014-09-09Labeling · Supplement 24AP
2012-12-29Labeling · Supplement 33 · standardAP
2012-03-26Labeling · Supplement 29AP
2008-02-05Labeling · Supplement 19AP
2007-02-09Labeling · Supplement 12AP
2003-06-06Labeling · Supplement 2AP
2002-07-22Manufacturing (CMC) · Supplement 1AP
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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