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FDA ANDA · ANDA040321

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA040321
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-05
LATEST ACTION
2002-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2002-02-05OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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