Cytarabine
Cytarabine Injection(For Intravenous, Intrathecal and Subcutaneous Use Only)
Approved
Approval ID
8105e590-fc7e-45b7-9604-c2d0d1be5eac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2020
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-109
Application NumberANDA205696
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cytarabine
Product Specifications
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateJuly 27, 2020
FDA Product Classification
INGREDIENTS (4)
waterInactive
Code: 059QF0KO0R
Classification: IACT
cytarabineActive
Quantity: 2 g in 20 mL
Code: 04079A1RDZ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT