Amphotericin B
Amphotericin B Liposome for Injection Rx only
Approved
Approval ID
6f24975c-5191-4fc2-a8da-e57358f8e154
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
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
NDC Product Code55150-365
Application NumberANDA214010
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2022
Generic NameAmphotericin B
INGREDIENTS (8)
CHOLESTEROLInactive
Quantity: 52 mg in 12.5 mL
Code: 97C5T2UQ7J
Classification: IACT
AMPHOTERICIN BActive
Quantity: 50 mg in 12.5 mL
Code: 7XU7A7DROE
Classification: ACTIB
.ALPHA.-TOCOPHEROLInactive
Quantity: 0.64 mg in 12.5 mL
Code: H4N855PNZ1
Classification: IACT
SODIUM SUCCINATE HEXAHYDRATEInactive
Quantity: 27 mg in 12.5 mL
Code: U16QOD6C4E
Classification: IACT
1,2-DISTEAROYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL))Inactive
Quantity: 84 mg in 12.5 mL
Code: Z16Y0357CV
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Quantity: 213 mg in 12.5 mL
Code: H1109Z9J4N
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Quantity: 900 mg in 12.5 mL
Code: C151H8M554
Classification: IACT