APPLICATION
ANDA075451
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 25 · standardAP
2017-08-04Labeling · Supplement 24 · standardAP
2014-11-02Labeling · Supplement 23 · standardAP
2014-09-03Labeling · Supplement 14AP
2013-01-29Labeling · Supplement 20 · standardAP
2012-05-29Labeling · Supplement 19AP
2007-02-12Labeling · Supplement 9AP
2005-04-20Labeling · Supplement 5AP
2002-10-11Manufacturing (CMC) · Supplement 2AP
2002-07-11Manufacturing (CMC) · 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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