← FDA Drug Approvals (Drugs@FDA)
COTEMPLA XR-ODT
NDA · New Drug Application · Sponsor: NEOS THERAPS INC · Approved 2017-06-19
Drug application
- FDA Application #
NDA205489- Application type
- New Drug Application
- Brand name
- COTEMPLA XR-ODT
- Generic name
- METHYLPHENIDATE
- Active ingredients
- METHYLPHENIDATE
- Dosage form
- TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NEOS THERAPS INC
- Manufacturer
- Neos Therapeutics Brands, LLC
- First approval
- 2017-06-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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