← FDA Drug Approvals (Drugs@FDA)
FOCALIN XR
NDA · New Drug Application · Sponsor: SANDOZ · Approved 2005-05-26
Drug application
- FDA Application #
NDA021802- Application type
- New Drug Application
- Brand name
- FOCALIN XR
- Generic name
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active ingredients
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SANDOZ
- Manufacturer
- Sandoz Inc
- First approval
- 2005-05-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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