APPLICATION
ANDA075935
TYPE
ANDA
ORIGINAL APPROVAL
2001-12-17
LATEST ACTION
2020-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOVASTATINDiscontinued
LOVASTATIN 20MG · TABLET · ORAL
LOVASTATINDiscontinued
LOVASTATIN 40MG · TABLET · ORAL
LOVASTATINDiscontinued
LOVASTATIN 10MG · TABLET · ORAL
Approval history
2020-09-25Labeling · Supplement 8 · standardAP
2017-08-04Labeling · Supplement 7 · standardAP
2017-07-24Labeling · Supplement 6 · standardAP
2008-03-16Labeling · Supplement 5AP
2007-02-12Labeling · Supplement 4AP
2005-08-18Labeling · Supplement 1AP
2001-12-17OriginalAP
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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