levoleucovorin
These highlights do not include all the information needed to use LEVOLEUCOVORIN INJECTION safely and effectively. See full prescribing information for LEVOLEUCOVORIN INJECTION. LEVOLEUCOVORIN injection, for intravenous use Initial U.S. Approval: 1952 (-leucovorin)
Approved
Approval ID
dbb3613c-78a9-4a96-a766-17e7a9e8809b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2020
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levoleucovorin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-279
Application NumberANDA210892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levoleucovorin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LEVOLEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 mL
Code: 778XL6VBS8
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 8.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT
Levoleucovorin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-278
Application NumberANDA210892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levoleucovorin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (4)
LEVOLEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 mL
Code: 778XL6VBS8
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 8.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT