| Product Information |
|
| Registration Number |
DRP-12824
|
| Generic Name |
Irinotecan (as hydrochloride)
|
| Brand Name |
None
|
| Dosage Strength |
20 mg/ mL (500 mg/ 25 mL)
|
| Dosage Form |
Concentrate Solution for Intravenous (I.V.) Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Topoisomerase 1 (TOP1) Inhibitor]
|
| Packaging |
Type I Tubular Glass Vial with Bromobutyl Rubber Stopper and Aluminum Seal x 25 mL (Box of 1's)
|
| Manufacturer |
Eugia Pharma Specialties Limited
|
| Country of Origin |
India
|
| Trader |
Aurobindo Pharma Pvt. Ltd.
|
| Importer |
Medethix, Inc.
|
| Distributor |
Medethix, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
11 October 2022
|
| Expiry Date |
11 October 2027
|