| Product Information |
|
| Registration Number |
DRP-12424-06
|
| Generic Name |
Omeprazole (as sodium monohydrate)
|
| Brand Name |
Amkomep
|
| Dosage Strength |
40 mg
|
| Dosage Form |
Lyophilized Powder for Injection (I.V.)
|
| 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 + 10 mL 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 |
|
| Importer |
GPC Geo Pharma Corporation
|
| Distributor |
AMK Pharma International Trading
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
18 August 2024
|
| Expiry Date |
04 August 2027
|