| Product Information |
|
| Registration Number |
DRP-10863
|
| Generic Name |
Ketorolac Tromethamine
|
| Brand Name |
Bellurak
|
| Dosage Strength |
30 mg/mL
|
| Dosage Form |
Solution For Injection (I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Nonsteroidal Anti-Inflammatory Drug
|
| Packaging |
USP Type I Clear glass ampoule with green color break x
1 mL (Box of 6 ampoules in PVC tray)
|
| Manufacturer |
PT. Phapros Tbk
|
| Country of Origin |
Indonesia
|
| Trader |
|
| Importer |
Bellus Life Solutions, Inc.
|
| Distributor |
Bellus Life Solutions, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
19 January 2022
|
| Expiry Date |
19 January 2027
|