| Product Information |
|
| Registration Number |
DRP-12424
|
| Generic Name |
Omeprazole (as sodium monohydrate)
|
| Brand Name |
Aciflux
|
| Dosage Strength |
40mg
|
| Dosage Form |
Lyophilized Powder for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Proton Pump Inhibitor
|
| Packaging |
10 mL amber and transparent USP Type II glass tubular vials sealed with gray butyl rubber stopper and blue aluminum plastic cap + 10mL USP Type I glass transparent colorless ampoule (Water for Injection as .diluent) [Box of 1’s]
|
| Manufacturer |
Reyoung Pharmaceutical Co., Ltd.
|
| Country of Origin |
China
|
| Trader |
N/A
|
| Importer |
GPC Geo Pharma Corporation
|
| Distributor |
GPC Geo Pharma Corporation
|
| Application Type |
Initial
|
| Issuance Date |
04 August 2022
|
| Expiry Date |
04 August 2027
|