| Product Information |
|
| Registration Number |
DRP-11792
|
| Generic Name |
Dexmedetomidine (As Hydrochloride)
|
| Brand Name |
Dexmed
|
| Dosage Strength |
100 mcg/ mL (200 mcg/2 mL)
|
| Dosage Form |
Concentrate Solution for Intravenous Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Hypnotic/Sedative
|
| Packaging |
USP Type I clear glass vial with chlorobutyl rubber stopper and sealed with aluminum flip off seal x 2 mL (net content). Box of 5's.
|
| Manufacturer |
Gland Pharma Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Biocare Lifesciences, Inc.
|
| Distributor |
Biocare Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
29 April 2022
|
| Expiry Date |
29 April 2027
|