AmBisome
AmBisome (amphotericin B) liposome for injection
Approved
Approval ID
f7be6506-4d20-401e-a0ff-02ad7c33158a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2020
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amphotericin B
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-3051
Application NumberNDA050740
Product Classification
M
Marketing Category
C73594
G
Generic Name
amphotericin B
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 6, 2018
FDA Product Classification
INGREDIENTS (1)
AMPHOTERICIN BActive
Quantity: 50 mg in 12.5 mL
Code: 7XU7A7DROE
Classification: ACTIB