0008-4510 : Mylotarg 5 mg/5ml Intravenous Injection, Powder, Lyophilized, for Solution


NDC0008-4510
Labeler: Wyeth Pharmaceuticals Inc., a Subsidiary of Pfizer Inc.
Product Type: Human Prescription Drug
Drug Name:  Mylotarg
Dosage Form: Intravenous Injection, Powder, Lyophilized, for Solution
Application #: BLA761060
Rev. Date: 


NDC Package Codes:

  • 0008-4510-01: 1 VIAL, SINGLE‑DOSE IN 1 CARTON (0008‑4510‑01) > 5 ML IN 1 VIAL, SINGLE‑DOSE

Active Ingredients:

  • Gemtuzumab Ozogamicin

Dosage Strength:

  • 5 mg/5mL

Pharmaceutical Classes:

  • CD33-directed Immunoconjugate [EPC]
  • CD33-directed Antibody Interactions [MoA]

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