| Product Information |
|
| Registration Number |
DRP-13233
|
| Generic Name |
Bupivacaine Hydrochloride
|
| Brand Name |
Bupisaph
|
| Dosage Strength |
5 mg/mL (0.5% w/v) (100 mg/20 mL)
|
| Dosage Form |
Solution for
Injection (Spinal)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I Flint Clear Vial with Bromo Butyl Rubber Stopper and Flip-off Seal x 20 mL (Box of 1's)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire
Lifesciences, Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
06 January 2023
|
| Expiry Date |
06 January 2028
|