| Product Information |
|
| Registration Number |
DRP-12459
|
| Generic Name |
Bendamustine Hydrochloride
|
| Brand Name |
Chronistin
|
| Dosage Strength |
2.5 mg/mL (25 mg and 100 mg)
|
| Dosage Form |
Lyophilized Powder for Concentrate Solution for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent (Nitrogen Mustard Analogue)
|
| Packaging |
Type I amber glass vial with bromobutyl rubber stopper with aluminum seal and blue PP flip-off cap x 26 mL-capacity (contains 25 mg Lyophilized Powder) (Box of l’s); 60 mL-capacity (contains 100 mg Lyophilized Powder) (Box of 1’s)
|
| Manufacturer |
Oncomed Manufacturing A.S.
|
| Country of Origin |
Czech Republic
|
| Trader |
N/A
|
| Importer |
Sandoz Philippines Corporation
|
| Distributor |
N/A
|
| Application Type |
Initial
|
| Issuance Date |
12 August 2022
|
| Expiry Date |
12 August 2027
|