| Product Information |
|
| Registration Number |
DRP-12792
|
| Generic Name |
Colistimethate Sodium
|
| Brand Name |
Colitas-2M
|
| Dosage Strength |
160 mg
(Equivalent to 2 million International Units)
|
| Dosage Form |
Lyophilized Powder for Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antibacterial (Polymyxin)
|
| Packaging |
10 mL-capacity USP Type I clear glass vial with grey bromobutyl rubber stopper and aluminum flip-off seal
(Box of 1's)
|
| Manufacturer |
Gufic Biosciences Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Suhitas Pharmaceuticals Inc.
|
| Distributor |
Suhitas Pharmaceuticals Inc.
|
| Application Type |
Initial
|
| Issuance Date |
07 October 2022
|
| Expiry Date |
07 October 2027
|