← FDA Drug Approvals (Drugs@FDA)
OMLYCLO
BLA · Biologics License Application · Sponsor: CELLTRION INC · Approved 2025-03-07
Drug application
- FDA Application #
BLA761399- Application type
- Biologics License Application
- Brand name
- OMLYCLO
- Generic name
- Omalizumab-Igec
- Active ingredients
- OMALIZUMAB-IGEC
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- CELLTRION INC
- First approval
- 2025-03-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown