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FDA ANDA · ANDA200908

LABETALOL HYDROCHLORIDE

Sponsor: PH HEALTH

APPLICATION
ANDA200908
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-10
LATEST ACTION
2012-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LABETALOL HYDROCHLORIDEDiscontinued
LABETALOL HYDROCHLORIDE 300MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEDiscontinued
LABETALOL HYDROCHLORIDE 100MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEDiscontinued
LABETALOL HYDROCHLORIDE 200MG · TABLET · ORAL

Approval history

2012-07-10Not Applicable · OriginalAP
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