Product NDC: | 63323-762 |
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: | 63323-762 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091376 |
Marketing Category: | ANDA |
Start Marketing Date: | 20101129 |
Package NDC: | 63323-762-10 |
Package Description: | 1 VIAL in 1 BOX (63323-762-10) > 4 mL in 1 VIAL |
NDC Code | 63323-762-10 |
Proprietary Name | Topotecan Hydrochloride |
Package Description | 1 VIAL in 1 BOX (63323-762-10) > 4 mL in 1 VIAL |
Product NDC | 63323-762 |
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 | 20101129 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | TOPOTECAN HYDROCHLORIDE |
Strength Number | 4 |
Strength Unit | mg/4mL |
Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |