| Product Information |
|
| Registration Number |
DRP-13236
|
| Generic Name |
Omeprazole (as Sodium)
|
| Brand Name |
Omeyou
|
| Dosage Strength |
40 mg
|
| Dosage Form |
Lyophilized Powder for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
10 mL-capacity USP Type II amber glass vial with gray butyl rubber stopper and blue aluminum plastic caps + USP Type I transparent glass ampoule x 10 mL water for injection (diluent) [Box of 1's]
|
| Manufacturer |
Reyoung Pharmaceutical Co. Ltd.
|
| Country of Origin |
China
|
| Trader |
N/A
|
| Importer |
Ambicare Pharmaceuticals Inc.
|
| Distributor |
Ambicare Pharmaceuticals Inc.
|
| Application Type |
Initial
|
| Issuance Date |
06 January 2023
|
| Expiry Date |
06 January 2028
|