| Product Information |
|
| Registration Number |
DRP-13063
|
| Generic Name |
Irinotecan Hydrochloride (as trihydrate)
|
| Brand Name |
Irixarri-100
|
| Dosage Strength |
20mg/mL (100 mg/5 mL)
|
| Dosage Form |
Concentrate Solution For I.V Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I Amber Colored Glass Vial with Grey
Bromobutyl Rubber Plug sealed with Flip-off Green Colored seal x 5 mL (Box of 1's)
|
| Manufacturer |
ADMAC Lifesciences
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
24 November 2022
|
| Expiry Date |
24 November 2027
|