| Product Information |
|
| Registration Number |
DRP-8777
|
| Generic Name |
Bupivacaine Hydrochloride
|
| Brand Name |
Bupsan
|
| Dosage Strength |
5 mg/mL (0.5% w/v)
|
| Dosage Form |
Solution for Intrathecal Injection
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
USP Type I clear glass ampoule x 5 mL & 10 mL (net content) Box of 5's and 1's
|
| Pharmacologic Category |
-
|
| Manufacturer |
Kamla Lifesciences Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
SRS Life Sciences Inc.
|
| Distributor |
Endure Medical Inc.
|
| Application Type |
Initial (Variation) (Reconstructed)
|
| Issuance Date |
31 January 2023
|
| Expiry Date |
28 December 2027
|