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FDA ANDA · ANDA203741

NEBIVOLOL HYDROCHLORIDE

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA203741
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-24
LATEST ACTION
2015-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE · TABLET · ORAL

Approval history

2015-06-24UNKNOWN · OriginalLetterAP
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