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] |