Product NDC: | 57665-331 |
Proprietary Name: | DepoCyt |
Non Proprietary Name: | Cytarabine |
Active Ingredient(s): | 50 mg/5mL & nbsp; Cytarabine |
Administration Route(s): | INTRATHECAL |
Dosage Form(s): | INJECTION, LIPID COMPLEX |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 57665-331 |
Labeler Name: | Sigma-Tau Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021041 |
Marketing Category: | NDA |
Start Marketing Date: | 20101022 |
Package NDC: | 57665-331-01 |
Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (57665-331-01) > 5 mL in 1 VIAL, SINGLE-USE |
NDC Code | 57665-331-01 |
Proprietary Name | DepoCyt |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (57665-331-01) > 5 mL in 1 VIAL, SINGLE-USE |
Product NDC | 57665-331 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Cytarabine |
Dosage Form Name | INJECTION, LIPID COMPLEX |
Route Name | INTRATHECAL |
Start Marketing Date | 20101022 |
Marketing Category Name | NDA |
Labeler Name | Sigma-Tau Pharmaceuticals, Inc. |
Substance Name | CYTARABINE |
Strength Number | 50 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |