| Product Information |
|
| Registration Number |
DRP-11342
|
| Generic Name |
Ondansetron (as hydrochloride dihydrate)
|
| Brand Name |
Onetic® 4
|
| Dosage Strength |
2 mg/mL (4 mg/2 mL)
|
| Dosage Form |
Solution For Injection (I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Serotonin (5HT3) Antagonist (Anti-emetic)
|
| Packaging |
Clear, Colorless Type I Borosilicate Glass Ampoule x 2mL (Box of 5's)
|
| Manufacturer |
PT. Pratapa Nirmala
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Exa Life Care Pharma Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial
|
| Issuance Date |
04 March 2022
|
| Expiry Date |
04 March 2027
|