| Product Information |
|
| Registration Number |
DRP-12370
|
| Generic Name |
Irinotecan hydrochloride (as trihydrate)
|
| Brand Name |
Imatiplex
|
| Dosage Strength |
20 mg/mL (100 mg/5 mL)
|
| Dosage Form |
Concentrate Solution for I.V.
Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Topoisomerase 1 (TOP 1) Inhibitor)
|
| Packaging |
USP Type I amber tubular glass vial with grey
bromobutyl rubber stopper and aluminum flip off light blue color seal x 5 mL (net content). Box of 1's.
|
| Manufacturer |
Shilpa Medicare Limited - Unit 4 Pharmaceutical Formulation Sez
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
27 July 2022
|
| Expiry Date |
27 July 2027
|