| Product Information |
|
| Registration Number |
DR-XY48412
|
| Generic Name |
Ropivacaine Hydrochloride
|
| Brand Name |
Rocaine
|
| Dosage Strength |
10 mg/mL (100 mg/10 mL)
|
| Dosage Form |
Solution for Injection (I.V.)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I clear glass ampoule x 10 mL in plastic tray (Box of 5's)
|
| Manufacturer |
Biomendi, S.A.
|
| Country of Origin |
Spain
|
| Trader |
N/A
|
| Importer |
Endure Medical, Inc.
|
| Distributor |
Endure Medical, Inc.
|
| Application Type |
DR-XY48412
|
| Issuance Date |
06 March 2023
|
| Expiry Date |
07 October 2027
|