| Product Information |
|
| Registration Number |
DRP-11897
|
| Generic Name |
Bendamustine Hydrochloride
|
| Brand Name |
Damuxin
|
| Dosage Strength |
2.5mg/mL
|
| Dosage Form |
Lyophilized Powder For Concentrate For Solution For IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Alkylating agent
|
| Packaging |
20 mL-capacity Type I glass vial with grey bromobutyl double slotted lyostopper and red aluminum flip-off seal (Box of 1’s)
|
| Manufacturer |
Shilpa Medicare Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
19 May 2022
|
| Expiry Date |
19 May 2027
|