| Product Information |
|
| Registration Number |
DRP-13160
|
| Generic Name |
Irinotecan (as Hydrochloride Trihydrate)
|
| Brand Name |
Irixarri-40
|
| Dosage Strength |
20 mg/mL (40 mg/2 mL)
|
| Dosage Form |
Concentrate Solution for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
2 mL in 5 mL-capacity USP Type I amber glass vial with grey bromobutyl rubber stopper and brown flip-off seal (Box of 1 vial x 2 mL)
|
| Manufacturer |
Admac Lifesciences
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ambica International Corporation.
|
| Distributor |
Ambica International Corporation.
|
| Application Type |
Initial
|
| Issuance Date |
12 December 2022
|
| Expiry Date |
12 December 2027
|