APPLICATION
ANDA075636
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 32 · standardAP
2017-08-04Labeling · Supplement 31 · standardAP
2014-11-02Labeling · Supplement 27 · standardAP
2013-03-25Labeling · Supplement 25 · standardAP
2012-10-09Labeling · Supplement 21 · standardAP
2012-05-30Labeling · Supplement 20AP
2011-02-16Labeling · Supplement 17AP
2005-09-15Labeling · Supplement 2AP
2005-09-15Labeling · Supplement 7AP
2002-12-20Manufacturing (CMC) · Supplement 4AP
2002-12-12Manufacturing (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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