| Product Information |
|
| Registration Number |
DRP-11700-01
|
| Generic Name |
Omeprazole (as sodium)
|
| Brand Name |
OROMEP
|
| Dosage Strength |
40 mg
|
| Dosage Form |
Lyophilized Powder for Intravenous Injection/Infusion
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Proton Pump Inhibitor
|
| Packaging |
10 mL Type I glass vial, with rubber stopper and flip-off seal (drug product) + 10 mL Type I glass ampoule (Sterile Water for Injection as diluent) (Box of 1's)
|
| Manufacturer |
Reyoung Pharmaceutical Co., Ltd.
|
| Country of Origin |
China
|
| Trader |
N/A
|
| Importer |
Sanimed Pharmaceuticals Inc.
|
| Distributor |
Oro Sinai Pharma and General Merchandise, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
11 July 2022
|
| Expiry Date |
25 April 2027
|