← FDA Drug Approvals (Drugs@FDA)
NAGLAZYME
BLA · Biologics License Application · Sponsor: BIOMARIN · Approved 2005-05-31
Drug application
- FDA Application #
BLA125117
- Application type
- Biologics License Application
- Brand name
- NAGLAZYME
- Generic name
- GALSULFASE
- Active ingredients
- GALSULFASE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- BIOMARIN
- Manufacturer
- BioMarin Pharmaceutical Inc.
- First approval
- 2005-05-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown