| Product Information |
|
| Registration Number |
DR-XY47784
|
| Generic Name |
Dexmedetomidine (as hydrochloride)
|
| Brand Name |
Predex
|
| Dosage Strength |
100 mcg/mL (200 mcg/2 mL)
|
| Dosage Form |
Concentrate for Solution for Infusion (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Hypnotic/Sedative
|
| Packaging |
2 mL USP Type I amber colored ampoule with white colored ring in Polyvinyl Chloride (PVC) tray (Box of 1's)
|
| Manufacturer |
Themis Medicare Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Innogen Pharmaceuticals, Inc.
|
| Distributor |
Innogen Pharmaceuticals, Inc.
|
| Application Type |
Monitored Release
|
| Issuance Date |
08 March 2022
|
| Expiry Date |
08 March 2027
|