Cytarabine
Cytarabine Injection(For Intravenous or Subcutaneous Use)
Approved
Approval ID
1be2668b-d76f-4c65-aea9-86c5c40889a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2022
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 Code71288-168
Application NumberANDA206190
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cytarabine
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 11, 2022
FDA Product Classification
INGREDIENTS (5)
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
cytarabineActive
Quantity: 20 mg in 1 mL
Code: 04079A1RDZ
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT