| Product Information |
|
| Registration Number |
DRP-11610
|
| Generic Name |
Dexmedetomidine (as hydrochloride)
|
| Brand Name |
none
|
| 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 |
2 mL USP Type I clear glass vial with Teflon rubber
stopper, aluminum seal, and royal blue flip-off cap (Box of 1's)
|
| Manufacturer |
Intas Pharmaceuticals Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Accord Healthcare Limited - Philippine Branch Office
|
| Distributor |
Accord Healthcare Limited - Philippine Branch Office
|
| Application Type |
Initial
|
| Issuance Date |
04 April 2022
|
| Expiry Date |
04 April 2027
|