Product NDC: | 63459-390 |
Proprietary Name: | TREANDA |
Non Proprietary Name: | bendamustine hydrochloride |
Active Ingredient(s): | 25 mg/5mL & nbsp; bendamustine hydrochloride |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63459-390 |
Labeler Name: | Cephalon, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022249 |
Marketing Category: | NDA |
Start Marketing Date: | 20080320 |
Package NDC: | 63459-390-08 |
Package Description: | 5 mL in 1 VIAL, SINGLE-USE (63459-390-08) |
NDC Code | 63459-390-08 |
Proprietary Name | TREANDA |
Package Description | 5 mL in 1 VIAL, SINGLE-USE (63459-390-08) |
Product NDC | 63459-390 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | bendamustine hydrochloride |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20080320 |
Marketing Category Name | NDA |
Labeler Name | Cephalon, Inc. |
Substance Name | BENDAMUSTINE HYDROCHLORIDE |
Strength Number | 25 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |