| Product NDC: | 16729-151 |
| Proprietary Name: | topotecan hydrochloride |
| Non Proprietary Name: | topotecan hydrochloride |
| Active Ingredient(s): | 4 mg/4mL & nbsp; topotecan hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16729-151 |
| Labeler Name: | Accord Healthcare Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202351 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130701 |
| Package NDC: | 16729-151-31 |
| Package Description: | 1 VIAL in 1 PACKAGE (16729-151-31) > 4 mL in 1 VIAL |
| NDC Code | 16729-151-31 |
| Proprietary Name | topotecan hydrochloride |
| Package Description | 1 VIAL in 1 PACKAGE (16729-151-31) > 4 mL in 1 VIAL |
| Product NDC | 16729-151 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | topotecan hydrochloride |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20130701 |
| Marketing Category Name | ANDA |
| Labeler Name | Accord Healthcare Inc. |
| Substance Name | TOPOTECAN HYDROCHLORIDE |
| Strength Number | 4 |
| Strength Unit | mg/4mL |
| Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |