← FDA DRUG APPROVALS

FDA NDA · NDA207960

QUILLICHEW ER

methylphenidate hydrochloride

Sponsor: NEXTWAVE PHARMS

APPLICATION
NDA207960
TYPE
NDA
ORIGINAL APPROVAL
2015-12-04
LATEST ACTION
2026-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE, CHEWABLE
MARKETING STATUS
Prescription

Products

QUILLICHEW ER · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE, CHEWABLE · ORAL
QUILLICHEW ER · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE, CHEWABLE · ORAL
QUILLICHEW ER · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE, CHEWABLE · ORAL

Approval history

2026-03-10Labeling · Supplement 21 · standard — Label ↗AP
2025-09-23Labeling · Supplement 18 · standard — Label ↗AP
2023-10-13Labeling · Supplement 16 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 12 · 901 required — Label ↗AP
2017-02-28Labeling · Supplement 5 · standard — Letter ↗AP
2017-01-04Labeling · Supplement 4 · 901 required — Label ↗AP
2015-12-04Type 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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