APPLICATION
ANDA077837
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-20
LATEST ACTION
2022-08-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SIMVASTATINPrescription
SIMVASTATIN 80MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 20MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 5MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 10MG · TABLET · ORAL
Approval history
2022-08-31Labeling · Supplement 41 · standardAP
2022-08-31Labeling · Supplement 42 · standardAP
2020-05-14Labeling · Supplement 40 · standardAP
2019-08-07Labeling · Supplement 39 · standardAP
2019-08-07Labeling · Supplement 38 · standardAP
2015-10-05Labeling · Supplement 35 · standardAP
2014-11-03Labeling · Supplement 29 · standardAP
2014-11-03Labeling · Supplement 30 · standardAP
2013-02-28Labeling · Supplement 27 · standardAP
2012-03-29Labeling · Supplement 25AP
2011-11-04Labeling · Supplement 24AP
2011-07-25Labeling · Supplement 22AP
2011-03-16Labeling · Supplement 19AP
2010-09-08Labeling · Supplement 18AP
2008-11-18Labeling · Supplement 15AP
2008-04-02Labeling · Supplement 2AP
2008-01-16Labeling · 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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