| Product Information |
|
| Registration Number |
DRP-10891
|
| Generic Name |
Ondansetron (as hydrochloride)
|
| Brand Name |
Nauzex
|
| Dosage Strength |
2 mg/mL (8 mg/4 mL)
|
| Dosage Form |
Solution for Injection (IM/IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antiemetic (5-HT3-Receptor Antagonist)
|
| Packaging |
Type I Amber Colored Glass Ampoule x 5 mL (Net
content: 4 mL) (Box of 1's)
|
| Manufacturer |
Aroma İlaç San. Ltd. Şti
|
| Country of Origin |
Turkey
|
| Trader |
|
| Importer |
Medinova Pharmaceutical, Inc.
|
| Distributor |
|
| Application Type |
Initial
|
| Issuance Date |
14 December 2021
|
| Expiry Date |
14 December 2026
|