| Product Information |
|
| Registration Number |
DRP-12287
|
| Generic Name |
Dexmedetomidine (as hydrochloride)
|
| Brand Name |
Dexmed
|
| Dosage Strength |
100 mcg/mL (200 mcg/2 mL)
|
| Dosage Form |
Concentrate for
Solution for Intravenous Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Hypnotic/Sedative
|
| Packaging |
2 mL net content Ph. Eur. Type I clear and colorless glass vial with grey bromobutyl rubber stopper and aluminum seal with white polypropylene flip-off cap (Box of 4's)
|
| Manufacturer |
PharmIdea SIA
|
| Country of Origin |
Latvia
|
| Trader |
|
| Importer |
Suhitas Pharmaceuticals, Inc.
|
| Distributor |
Suhitas Pharmaceuticals, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
08 July 2022
|
| Expiry Date |
08 July 2027
|