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FDA ANDA · ANDA076655

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: ACTAVIS LABS FL

APPLICATION
ANDA076655
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-21
LATEST ACTION
2018-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval), Prescription

Products

METHYLPHENIDATE HYDROCHLORIDENone (Tentative Approval)
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDENone (Tentative Approval)
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 72MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-03-21OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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