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FDA ANDA · ANDA200082

EZETIMIBE AND SIMVASTATIN

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA200082
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-17
LATEST ACTION
2024-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 40MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 10MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 80MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 20MG · TABLET · ORAL

Approval history

2024-07-10Labeling · Supplement 2 · standardAP
2020-12-17OriginalAP
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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