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FDA NDA · NDA205831

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: RHODES PHARMS

APPLICATION
NDA205831
TYPE
NDA
ORIGINAL APPROVAL
2015-04-17
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
APTENSIO XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 12 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 8 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 6 · 901 required — Letter ↗AP
2019-06-14Efficacy · Supplement 5 · priority — Label ↗AP
2017-01-04Labeling · Supplement 3 · 901 required — Label ↗AP
2015-09-15Manufacturing (CMC) · Supplement 2 · standardAP
2015-04-17Type 3 - New Dosage Form · Original · standard — Pediatric Medical Review ↗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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