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FDA ANDA · ANDA076285

SIMVASTATIN

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA076285
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-23
LATEST ACTION
2009-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2009-10-05Labeling · Supplement 13AP
2008-06-18Labeling · Supplement 9AP
2006-12-20Labeling · Supplement 4AP
2006-12-20Manufacturing (CMC) · Supplement 2AP
2006-12-20Manufacturing (CMC) · Supplement 3AP
2006-06-23Original — 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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