| Product Information |
|
| Registration Number |
DRP-11994
|
| Generic Name |
Ondansetron (As Hydrochloride Dihydrate)
|
| Brand Name |
Onetic 8
|
| Dosage Strength |
2 mg/mL (8 mg/4 mL)
|
| Dosage Form |
Solution for Injection (I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antiemetic and Antinauseant
|
| Packaging |
Type I clear, colorless glass ampoule x 4 mL (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 |
27 May 2022
|
| Expiry Date |
27 May 2027
|