NDC 0008-4510
Mylotarg 5 mg per 5 mL injection, powder, lyophilized, for solution
On the label: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Andover, MA, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyApr 8, 2026 · 5 inspections |
| Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pearl River, NY, United States | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 3 inspections |
| Pharmacia & Upjohn Company LLC | Kalamazoo, MI, United States | Tests it and labels it | Problems found, fixed voluntarilyJun 16, 2023 · 9 inspections |
Product details
- Generic drug
- Gemtuzumab Ozogamicin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 5 mg per 5 mL
- Approval
- BLA BLA761060
- On the market since
- Sep 7, 2017
- Package NDCs
0008-4510-01- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2025
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