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FDA ANDA · ANDA040410

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA040410
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-09
LATEST ACTION
2008-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2008-09-23Labeling · Supplement 9AP
2003-01-21Labeling · Supplement 4AP
2001-09-17Manufacturing (CMC) · Supplement 2AP
2001-02-09Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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