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FDA ANDA · ANDA074835

NORTRIPTYLINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA074835
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-30
LATEST ACTION
1997-06-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL

Approval history

1997-06-30OriginalAP
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