← FDA Drug Approvals (Drugs@FDA)
SIMLANDI
BLA · Biologics License Application · Sponsor: ALVOTECH USA INC · Approved 2024-02-23
Drug application
- FDA Application #
BLA761299
- Application type
- Biologics License Application
- Brand name
- SIMLANDI
- Generic name
- ADALIMUMAB-RYVK
- Active ingredients
- ADALIMUMAB-RYVK
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- ALVOTECH USA INC
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- First approval
- 2024-02-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown