QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE)
Summary
FDA approved QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) by NEXTWAVE PHARMS. NDA (New Drug) approval (Labeling) on 2026-03-10. TABLET, EXTENDED RELEASE, CHEWABLE, ORAL.
Details
Source
Drug Approval
External ID
NDA207960-21
Action Date
2026-03-10
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
QUILLICHEW ER (generic: METHYLPHENIDATE HYDROCHLORIDE), TABLET, EXTENDED RELEASE, CHEWABLE, ORAL. Application: NDA207960
Company
Context & Analysis
Frequently Asked Questions
How often does NEXTWAVE PHARMS have FDA actions?
This is the only FDA action we have on record for NEXTWAVE PHARMS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA207960-21" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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