← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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