Cytarabine
Cytarabine Injection Rx only For Intravenous, Intrathecal and Subcutaneous Use Only.
Approved
Approval ID
cb0db038-4a65-42c7-aa79-5c88309061df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 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 Code68083-337
Application NumberANDA211938
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cytarabine
Product Specifications
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateJuly 14, 2020
FDA Product Classification
INGREDIENTS (4)
CYTARABINEActive
Quantity: 100 mg in 1 mL
Code: 04079A1RDZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT