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FDA ANDA · ANDA204659

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA204659
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-15
LATEST ACTION
2024-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-04-01Labeling · Supplement 1 · standardAP
2019-07-15UNKNOWN · Original · standardAP
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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