| Product Information |
|
| Registration Number |
DRP-14807
|
| Generic Name |
Irinotecan Hydrochloride (as trihydrate)
|
| Brand Name |
None
|
| Dosage Strength |
20 mg/mL (100 mg/5 mL)
|
| Dosage Form |
Concentrate Solution for IV Infusion
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Antineoplastic
|
| Packaging |
Type I amber glass vial with grey bromobutyl rubber stopper, aluminum seal, and light blue flip-off cap (Box of 1's)
|
| Manufacturer |
Shilpa Medicare Limited (Unit-4, Pharmaceutical
Formulations Sez)
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Biocare Lifesciences, Inc.
|
| Distributor |
Biocare Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
12 January 2024
|
| Expiry Date |
12 January 2029
|