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
fdaa7d15-7c06-44ab-b1d5-9d2b3e8ffd28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code72603-411
Application NumberANDA210046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateOctober 11, 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 Code72603-104
Application NumberANDA210046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 500 mg in 25 mL
Code: 8N3DW7272P
Classification: ACTIM
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-326
Application NumberANDA210046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 1 g in 50 mL
Code: 8N3DW7272P
Classification: ACTIM