Product NDC: | 63323-194 |
Proprietary Name: | Idarubicin Hydrochloride |
Non Proprietary Name: | IDARUBICIN HYDROCHLORIDE |
Active Ingredient(s): | 1 mg/mL & nbsp; IDARUBICIN HYDROCHLORIDE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-194 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA065440 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090811 |
Package NDC: | 63323-194-20 |
Package Description: | 1 VIAL in 1 CARTON (63323-194-20) > 20 mL in 1 VIAL |
NDC Code | 63323-194-20 |
Proprietary Name | Idarubicin Hydrochloride |
Package Description | 1 VIAL in 1 CARTON (63323-194-20) > 20 mL in 1 VIAL |
Product NDC | 63323-194 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | IDARUBICIN HYDROCHLORIDE |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20090811 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | IDARUBICIN HYDROCHLORIDE |
Strength Number | 1 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] |