| Product Information |
|
| Registration Number |
DRP-14802
|
| Generic Name |
Ondansetron (as hydrochloride dihydrate)
|
| Brand Name |
Ondero
|
| Dosage Strength |
2 mg/mL
|
| Dosage Form |
Solution for Injection (I.M./I.V.)
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Antiemetic/Antinauseant [Serotonin (5HT3) Antagonist]
|
| Packaging |
2 mL-net content USP Type I clear and colorless glass vial with grey bromobutyl rubber stopper and light blue aluminum seal with light blue PP flip-off cap (Box of 1's)
|
| Manufacturer |
Aspiro Pharma Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Camber Pharmaceuticals, Inc.
|
| Distributor |
Camber Pharmaceuticals, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
11 January 2024
|
| Expiry Date |
11 January 2029
|