Cyclophosphamide
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959
Approved
Approval ID
520bfe39-dfd5-4a20-9a37-80078afded0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1239
Application NumberANDA210046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 1 g in 50 mL
Code: 8N3DW7272P
Classification: ACTIM
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1240
Application NumberANDA210046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 2 g in 100 mL
Code: 8N3DW7272P
Classification: ACTIM
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1238
Application NumberANDA210046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 500 mg in 25 mL
Code: 8N3DW7272P
Classification: ACTIM