| Product Information |
|
| Registration Number |
DRP-12925
|
| Generic Name |
Bupivacaine hydrochloride (as monohydrate)
|
| Brand Name |
Duvacaine
|
| Dosage Strength |
5 mg/mL (0.5% w/v)
|
| Dosage Form |
Solution for Injection (for Peripheral Nerve Block, Caudal Block, and Lumbar Epidural Block)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Local Anesthetic (Amide)
|
| Packaging |
20 mL Type I clear and colorless glass vial enclosed with gray siliconized rubber closure and aluminum seal with blue PP flip-off button (5 vials per unit PVC tray) [Box of 5 vials]
|
| Manufacturer |
Pharmaniaga Lifescience Sdn. Bhd.
|
| Country of Origin |
Malaysia
|
| Trader |
N/A
|
| Importer |
Duopharma Trade Phils., Inc.
|
| Distributor |
Duopharma Trade Phils., Inc.
|
| Application Type |
Initial
|
| Issuance Date |
02 November 2022
|
| Expiry Date |
02 November 2027
|