← FDA Drug Approvals (Drugs@FDA)
KUVAN
NDA · New Drug Application · Sponsor: BIOMARIN PHARM · Approved 2013-12-19
Drug application
- FDA Application #
NDA205065- Application type
- New Drug Application
- Brand name
- KUVAN
- Generic name
- SAPROPTERIN DIHYDROCHLORIDE
- Active ingredients
- SAPROPTERIN DIHYDROCHLORIDE
- Dosage form
- POWDER
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BIOMARIN PHARM
- Manufacturer
- BioMarin Pharmaceutical Inc.
- First approval
- 2013-12-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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