| Product NDC: | 47335-953 |
| 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: | 47335-953 |
| Labeler Name: | Sun Pharma Global FZE |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078805 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080421 |
| Package NDC: | 47335-953-40 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 CARTON (47335-953-40) > 5 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 47335-953-40 |
| Proprietary Name | IRINOTECAN HYDROCHLORIDE |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (47335-953-40) > 5 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 47335-953 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | IRINOTECAN HYDROCHLORIDE |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20080421 |
| Marketing Category Name | ANDA |
| Labeler Name | Sun Pharma Global FZE |
| Substance Name | IRINOTECAN HYDROCHLORIDE |
| Strength Number | 100 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |