| Product Information |
|
| Registration Number |
DRP-13387
|
| Generic Name |
Citicoline (as sodium)
|
| Brand Name |
Brainolin
|
| Dosage Strength |
125mg/mL
|
| Dosage Form |
Solution For Injection (IM/IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
10 mL-Capacity USP Type I Glass Ampoule x 8 mL (net content) (Box of 5ampoules x 8 mL)
|
| Manufacturer |
PT Ferron Par Pharmaceuticals
|
| Country of Origin |
Indonesia
|
| Trader |
PT Dexa Medica
|
| Importer |
Glorious Dexa Mandaya, Inc.
|
| Distributor |
Glorious Dexa Mandaya, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
09 February 2023
|
| Expiry Date |
09 February 2028
|