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JORNAY PM

NDA · New Drug Application · Sponsor: IRONSHORE PHARMS · Approved 2018-08-08

Drug application

FDA Application #
NDA209311
Application type
New Drug Application
Brand name
JORNAY PM
Generic name
METHYLPHENIDATE HYDROCHLORIDE
Active ingredients
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
IRONSHORE PHARMS
Manufacturer
Ironshore Pharmaceuticals Inc.
First approval
2018-08-08

Source

Authoritative
Drugs@FDA application overview
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