| Product Information |
|
| Registration Number |
DRP-13907
|
| Generic Name |
Irinotecan Hydrochloride
|
| Brand Name |
None
|
| Dosage Strength |
20 mg/mL (100 mg/5 mL)
|
| Dosage Form |
Concentrate Solution for
Intravenous Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I tubular amber glass vial with gray bromobutyl rubber stopper and aluminum seal with sky blue polypropylene disc x 5.
SC x 5 mL (Box of 1's)
|
| Manufacturer |
Eugia Pharma Specialities Limited
|
| Country of Origin |
India
|
| Trader |
Aurobindo Pharma Limited
|
| Importer |
Medethix, Inc.
|
| Distributor |
Medethix, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
16 May 2023
|
| Expiry Date |
16 May 2028
|