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FDA NDA · NDA216117

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: OSMOTICA PHARM US

APPLICATION
NDA216117
TYPE
NDA
ORIGINAL APPROVAL
2022-06-23
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 72MG · TABLET, EXTENDED RELEASE · ORAL
RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL
RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 18MG · TABLET, EXTENDED RELEASE · ORAL
RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 63MG · TABLET, EXTENDED RELEASE · ORAL
RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 45MG · TABLET, EXTENDED RELEASE · ORAL
RELEXXII · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 27MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 3 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 1 · standard — Letter ↗AP
2022-06-23Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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