| Product Information |
|
| Registration Number |
DRP-12247
|
| Generic Name |
Bendamustine Hydrochloride (as monohydrate)
|
| Brand Name |
Fonkomustin
|
| Dosage Strength |
100 mg
|
| Dosage Form |
Lyophilized Powder For Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Nitrogen Mustard Analogue)
|
| Packaging |
USP Type I amber glass vial with grey bromo butyl
rubber stopper and blue flip off seal x 20 mL (Box of 1’s)
|
| Manufacturer |
PT. Fonko International Pharmaceuticals
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Glorious Dexa Mandaya, Inc.
|
| Distributor |
Glorious Dexa Mandaya, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
01 July 2022
|
| Expiry Date |
01 July 2027
|