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FDA ANDA · ANDA077959

MIRTAZAPINE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA077959
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-14
LATEST ACTION
2011-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

MIRTAZAPINEDiscontinued
MIRTAZAPINE 45MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 30MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2011-02-14OriginalAP
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