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, solution for intravenous use Initial U.S. Approval: 1952 (d,l-leucovorin), 2008 (levoleucovorin)
Approved
Approval ID
c003aaed-89c3-d6a6-0d34-18851b7e1255
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2017
Manufacturers
FDA
Dr.Reddy's Laboratories Inc
DUNS: 802315887
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 Code43598-771
Application NumberANDA210892
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOLEUCOVORIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 20, 2018
FDA Product Classification
INGREDIENTS (4)
Levoleucovorin CalciumActive
Quantity: 175 mg in 17.5 mL
Code: 778XL6VBS8
Classification: ACTIM
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
LEVOLEUCOVORIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-773
Application NumberANDA210892
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOLEUCOVORIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 20, 2018
FDA Product Classification
INGREDIENTS (4)
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Levoleucovorin CalciumActive
Quantity: 250 mg in 25 mL
Code: 778XL6VBS8
Classification: ACTIM
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT