Folotyn
These highlights do not include all the information needed to use FOLOTYN safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009
Approved
Approval ID
9f3d9c4d-9386-4451-b712-0fbdc5478d8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
Acrotech Biopharma Inc
DUNS: 116965616
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pralatrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72893-005
Application NumberNDA022468
Product Classification
M
Marketing Category
C73594
G
Generic Name
pralatrexate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (5)
PRALATREXATEActive
Quantity: 40 mg in 2 mL
Code: A8Q8I19Q20
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
pralatrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72893-003
Application NumberNDA022468
Product Classification
M
Marketing Category
C73594
G
Generic Name
pralatrexate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PRALATREXATEActive
Quantity: 20 mg in 1 mL
Code: A8Q8I19Q20
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT