← FDA DRUG APPROVALS

FDA ANDA · ANDA077752

SIMVASTATIN

Sponsor: RISING

APPLICATION
ANDA077752
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-20
LATEST ACTION
2015-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SIMVASTATINPrescription
SIMVASTATIN 5MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 10MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 80MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 20MG · TABLET · ORAL

Approval history

2015-10-05Labeling · Supplement 22 · standardAP
2014-11-03Labeling · Supplement 20 · standardAP
2014-11-03Labeling · Supplement 21 · standardAP
2013-01-29Labeling · Supplement 19 · standardAP
2012-04-30Labeling · Supplement 18AP
2012-01-11Labeling · Supplement 17AP
2011-07-25Labeling · Supplement 16AP
2010-12-21Labeling · Supplement 15AP
2010-09-27Labeling · Supplement 14AP
2010-04-30Labeling · Supplement 13AP
2008-09-10Labeling · Supplement 9AP
2008-02-06Labeling · Supplement 4AP
2006-12-20Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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