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QUILLICHEW ER

NDA · New Drug Application · Sponsor: NEXTWAVE PHARMS · Approved 2015-12-04

Drug application

FDA Application #
NDA207960
Application type
New Drug Application
Brand name
QUILLICHEW ER
Generic name
METHYLPHENIDATE HYDROCHLORIDE
Active ingredients
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE, CHEWABLE
Route
ORAL
Marketing status
Prescription
Sponsor
NEXTWAVE PHARMS
Manufacturer
NextWave Pharmaceuticals, Inc
First approval
2015-12-04

Source

Authoritative
Drugs@FDA application overview
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