| Product Information |
|
| Registration Number |
DRP-9126-01
|
| Generic Name |
Rocuronium bromide
|
| Brand Name |
Rocutam
|
| Dosage Strength |
10 mg / mL (50 mg / 5 mL)
|
| Dosage Form |
Solution for Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Muscle Relaxant (Quaternary Ammonium Compound)
|
| Packaging |
USP Type I clear and colorless glass vial with grey chlorobutyl rubber stopper and red-colored aluminum seal with yellowcolored flip-off cap x 5 mL / (Box of 10's)
|
| Manufacturer |
Maiva Pharma Private Limited
|
| Country of Origin |
India
|
| Trader |
I-Care Formulations
|
| Importer |
Medethix, Inc.
|
| Distributor |
Tamiga Pharmaceuticals Supply
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
12 July 2024
|
| Expiry Date |
18 September 2028
|