| Product Information |
|
| Registration Number |
DRP-13250
|
| Generic Name |
Lidocaine Hydrochloride +
Epinephrine (As Bitartrate),
|
| Brand Name |
Royaledent®
|
| Dosage Strength |
20mg/10mcg per mL
|
| Dosage Form |
Solution For Injection (Local Infiltration)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I Clear and colorless glass cartridge grey-coloured bromobutyl stopper on one side and bromobutyl coated disk and aluminum cap on the other side x 1.8 mL in Alu/PVC Blister pack x 10's (Box of 50's)
|
| Manufacturer |
Royale Life Pharma Inc.
|
| Country of Origin |
Philippines
|
| Trader |
N/A
|
| Importer |
N/A
|
| Distributor |
N/A
|
| Application Type |
Initial
|
| Issuance Date |
19 January 2023
|
| Expiry Date |
19 January 2028
|