Product NDC: | 57884-3002 |
Proprietary Name: | IRINOTECAN HYDROCHLORIDE |
Non Proprietary Name: | IRINOTECAN HYDROCHLORIDE |
Active Ingredient(s): | 100 mg/5mL & nbsp; IRINOTECAN HYDROCHLORIDE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 57884-3002 |
Labeler Name: | Jiangsu Hengrui Pharmaceutical Co., Ltd. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090675 |
Marketing Category: | ANDA |
Start Marketing Date: | 20111216 |
Package NDC: | 57884-3002-1 |
Package Description: | 1 VIAL in 1 CARTON (57884-3002-1) > 5 mL in 1 VIAL |
NDC Code | 57884-3002-1 |
Proprietary Name | IRINOTECAN HYDROCHLORIDE |
Package Description | 1 VIAL in 1 CARTON (57884-3002-1) > 5 mL in 1 VIAL |
Product NDC | 57884-3002 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | IRINOTECAN HYDROCHLORIDE |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20111216 |
Marketing Category Name | ANDA |
Labeler Name | Jiangsu Hengrui Pharmaceutical Co., Ltd. |
Substance Name | IRINOTECAN HYDROCHLORIDE |
Strength Number | 100 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |