| Product Information |
DR-XY47945_PI_01.pdf
|
| Registration Number |
DR-XY47945
|
| Generic Name |
Bendamustine Hydrochloride (as monohydrate)
|
| Brand Name |
Bentero 25
|
| Dosage Strength |
25 mg
|
| Dosage Form |
Lyophilized Powder for Concentrate for
Solution for I.V. Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent (Nitrogen Mustard Analogue)
|
| Packaging |
10 mL-capacity USP Type I amber glass vial with
gray bromo butyl rubber stopper and aluminum seal with blue colored plastic flip-off cap (Box of 1's)
|
| Manufacturer |
Hetero Labs Limited (Unit-VI)
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Camber Pharmaceuticals, Inc.
|
| Distributor |
Camber Pharmaceuticals, Inc.
|
| Application Type |
Monitored Release (CPR Correction)
|
| Issuance Date |
19 August 2022
|
| Expiry Date |
19 April 2025
|