| Product Information |
|
| Registration Number |
DRP-12540
|
| Generic Name |
Meropenem (As Trihydrate)
|
| Brand Name |
One-Mero 500
|
| Dosage Strength |
500 mg
|
| Dosage Form |
Powder for Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antibacterial (Carbapenem)
|
| Packaging |
Type I Clear Glass Vial x 20 mL with bromobutyl rubber
stopper and aluminum flip-off seal (Box of 1's)
|
| Manufacturer |
Brooks Laboratories Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
One Dexcel Pharma Inc.
|
| Distributor |
One Dexcel Pharma Inc.
|
| Application Type |
Initial (Reconstruction)
|
| Issuance Date |
06 February 2024
|
| Expiry Date |
30 August 2027
|