← FDA Drug Approvals (Drugs@FDA)
STALEVO 75
NDA · New Drug Application · Sponsor: ORION PHARMA · Approved 2003-06-11
Drug application
- FDA Application #
NDA021485- Application type
- New Drug Application
- Brand name
- STALEVO 75
- Generic name
- CARBIDOPA, LEVODOPA, AND ENTACAPONE
- Active ingredients
- CARBIDOPA; ENTACAPONE; LEVODOPA
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ORION PHARMA
- Manufacturer
- Sandoz Inc
- First approval
- 2003-06-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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