← FDA DRUG APPROVALS

FDA NDA · NDA202100

QUILLIVANT XR

methylphenidate hydrochloride

Sponsor: NEXTWAVE

APPLICATION
NDA202100
TYPE
NDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2026-03-09
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QUILLIVANT XR · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG/ML · FOR SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2026-03-09Labeling · Supplement 25 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 24 · standard — Label ↗AP
2023-10-13Labeling · Supplement 23 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 18 · 901 required — Label ↗AP
2017-01-24Labeling · Supplement 6 · standard — Label ↗AP
2017-01-04Labeling · Supplement 12 · 901 required — Label ↗AP
2016-05-27Manufacturing (CMC) · Supplement 8 · standardAP
2016-05-13Labeling · Supplement 7 · standard — Label ↗AP
2015-07-13Labeling · Supplement 5 · standard — Label ↗AP
2015-04-17Labeling · Supplement 4 · 901 required — Label ↗AP
2013-12-12Labeling · Supplement 3 · standard — Label ↗AP
2013-08-09Labeling · Supplement 2 · standard — Label ↗AP
2013-05-15Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2012-09-27Type 3 - New Dosage Form · Original · standard — Label ↗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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