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FDA NDA · NDA212038

ADHANSIA XR

Sponsor: KNOA PHARMA

APPLICATION
NDA212038
TYPE
NDA
ORIGINAL APPROVAL
2019-02-27
LATEST ACTION
2021-06-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ADHANSIA XR · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 70MG · CAPSULE, EXTENDED RELEASE · ORAL
ADHANSIA XR · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 45MG · CAPSULE, EXTENDED RELEASE · ORAL
ADHANSIA XR · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL
ADHANSIA XR · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 85MG · CAPSULE, EXTENDED RELEASE · ORAL
ADHANSIA XR · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 55MG · CAPSULE, EXTENDED RELEASE · ORAL
ADHANSIA XR · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2021-06-28Efficacy · Supplement 2 · standard — Label ↗AP
2021-06-25Labeling · Supplement 5 · 901 required — Label ↗AP
2019-07-03Labeling · Supplement 1 · standard — Letter ↗AP
2019-02-27Type 3 - New Dosage Form · Original · standard — Label ↗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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