| Product Information |
|
| Registration Number |
DRP-11119-01
|
| Generic Name |
Palonosetron (as hydrochloride)
|
| Brand Name |
X-Noseia
|
| Dosage Strength |
50 mcg/mL (250 mcg/5 mL)
|
| Dosage Form |
Solution for Intravenous Injection
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
-
|
| Packaging |
5 mL (net content) USP/Ph. Eur. Type I Clear and colorless glass vial with gray bromobutyl rubber stopper and aluminum seal with blue flip-off cap (Box of 1 vial)
|
| Manufacturer |
USV Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
I.E. Medica, Inc.
|
| Distributor |
Medethix, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
24 October 2022
|
| Expiry Date |
04 February 2027
|