| Product Information |
|
| Registration Number |
DRP-12537
|
| Generic Name |
Meropenem (as trihydrate)
|
| Brand Name |
One-Mero 1000
|
| Dosage Strength |
1 g
|
| Dosage Form |
Powder for Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antibacterial (Carbapenem)
|
| Packaging |
20 mL-capacity Type I Clear Glass Vial with Bromobutyl rubber stopper and Aluminum Flip-off Seal (Box of 1's)
|
| Manufacturer |
Brooks Steriscience Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
One Dexcel Pharma Inc.
|
| Distributor |
One Dexcel Pharma Inc.
|
| Application Type |
Initial (Reconstruction)
|
| Issuance Date |
29 May 2024
|
| Expiry Date |
31 August 2027
|