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FDA ANDA · ANDA090868

SIMVASTATIN

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA090868
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-08
LATEST ACTION
2024-05-30
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

2024-05-30Labeling · Supplement 7 · standardAP
2016-11-14Labeling · Supplement 5 · standardAP
2012-05-01Labeling · Supplement 4AP
2012-01-11Labeling · Supplement 3AP
2010-06-08Original — 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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