| Product Information |
|
| Registration Number |
DRP-13449
|
| Generic Name |
Irinotecan Hydrochloride
|
| Brand Name |
None
|
| Dosage Strength |
20 mg/mL (300 mg/15 mL)
|
| Dosage Form |
Concentrate Solution For IV 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 15 mL (Box of 1's)
|
| Manufacturer |
Eugia Pharma Specialities Limited
|
| Country of Origin |
India
|
| Trader |
Aurobindo Pharma Ltd.
|
| Importer |
Medethix, Inc.
|
| Distributor |
Medethix, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
22 February 2023
|
| Expiry Date |
22 February 2028
|