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FDA ANDA · ANDA078469

ALPRAZOLAM

Sponsor: PH HEALTH

APPLICATION
ANDA078469
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-29
LATEST ACTION
2011-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.5MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 3MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 1MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 2MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2011-09-29OriginalAP
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