| Product Information |
|
| Registration Number |
DRP-12886
|
| Generic Name |
Bupivacaine Hydrochloride
|
| Brand Name |
Anesticaine
|
| 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 |
10 mL Type I clear and colorless glass ampoule with break ring or one-point cut, placed in a PVC tray (Box of 5's)
|
| Manufacturer |
HBM Pharma S.R.O.
|
| Country of Origin |
Slovak Republic
|
| Trader |
kciju Sabiedriba "Grindeks" (Site I)
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
25 October 2022
|
| Expiry Date |
25 October 2027
|