Cytarabine
Cytarabine Injection For Intravenous, Intrathecal and Subcutaneous Use Only Rx only
Approved
Approval ID
7ab50348-ca78-46a5-aba6-c35b6b21fbfe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2020
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cytarabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-343
Application NumberANDA211937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cytarabine
Product Specifications
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateJuly 13, 2020
FDA Product Classification
INGREDIENTS (5)
CYTARABINEActive
Quantity: 20 mg in 1 mL
Code: 04079A1RDZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 6.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT