| Product Information |
|
| Registration Number |
DRP-12506
|
| Generic Name |
Ondansetron (As Hydrochloride)
|
| Brand Name |
Saphdosetron
|
| Dosage Strength |
2mg/ml (8mg/4ml) (4mg/2ml)
|
| Dosage Form |
Solution For Injection (IM/IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antiemetic/Antinauseant [Serotonin (5HT3) antagonist]
|
| Packaging |
Type I Clear Glass Ampoule in PVC Tray x 2 mL and 4 mL (Box of 5's, 10's and 25's)
|
| Manufacturer |
Bruck Pharma Private Limited
|
| Country of Origin |
india
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
22 August 2022
|
| Expiry Date |
22 August 2027
|