← FDA Drug Approvals (Drugs@FDA)
MYLOTARG
BLA · Biologics License Application · Sponsor: WYETH PHARMS INC · Approved 2017-09-01
Drug application
- FDA Application #
BLA761060- Application type
- Biologics License Application
- Brand name
- MYLOTARG
- Generic name
- GEMTUZUMAB OZOGAMICIN
- Active ingredients
- GEMTUZUMAB OZOGAMICIN
- Dosage form
- VIAL
- Route
- SINGLE-DOSE
- Marketing status
- Prescription
- Sponsor
- WYETH PHARMS INC
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- First approval
- 2017-09-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown