| Product NDC: | 53104-0151 |
| Proprietary Name: | Irinotecan Hydrochloride |
| Non Proprietary Name: | Irinotecan Hydrochloride |
| Active Ingredient(s): | 20 mg/mL & nbsp; Irinotecan Hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 53104-0151 |
| Labeler Name: | Cipla Limited |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077219 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080220 |
| Package NDC: | 53104-0151-3 |
| Package Description: | 1 VIAL in 1 CARTON (53104-0151-3) > 5 mL in 1 VIAL |
| NDC Code | 53104-0151-3 |
| Proprietary Name | Irinotecan Hydrochloride |
| Package Description | 1 VIAL in 1 CARTON (53104-0151-3) > 5 mL in 1 VIAL |
| Product NDC | 53104-0151 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Irinotecan Hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20080220 |
| Marketing Category Name | ANDA |
| Labeler Name | Cipla Limited |
| Substance Name | IRINOTECAN HYDROCHLORIDE |
| Strength Number | 20 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |