# Mylotarg

NDC: 0008-4510
Generic name: gemtuzumab ozogamicin
Labeler / Manufacturer: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Biologic License Application
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes: INTRAVENOUS
Marketing started: 20170907

FDA application: BLA761060

## Active ingredients

- GEMTUZUMAB OZOGAMICIN: 5 mg/5mL

## Pharmacological class

—

## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0008-4510"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0008-4510
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=32fd2bb2-1cfa-4250-feb8-d7956c794e05