CYCLOPHOSPHAMIDE
"These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively". "See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES." "CYCLOPHOSPHAMIDE capsules" "Initial U.S. Approval: 1959"
Approved
Approval ID
4ebe66e7-5e0d-41ff-8ef9-e4c30a65f213
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
STI Pharma LLC
DUNS: 832714070
Products 2
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 Code54879-021
Application NumberANDA209872
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYCLOPHOSPHAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CYCLOPHOSPHAMIDEActive
Quantity: 25 mg in 1 1
Code: 8N3DW7272P
Classification: ACTIM
CYCLOPHOSPHAMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54879-022
Application NumberANDA209872
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYCLOPHOSPHAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (15)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CYCLOPHOSPHAMIDEActive
Quantity: 50 mg in 1 1
Code: 8N3DW7272P
Classification: ACTIM