Product NDC: | 67457-176 |
Proprietary Name: | Sotalol hydrochloride |
Non Proprietary Name: | Sotalol hydrochloride |
Active Ingredient(s): | 15 mg/mL & nbsp; Sotalol hydrochloride |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 67457-176 |
Labeler Name: | Bioniche Pharma USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022306 |
Marketing Category: | NDA |
Start Marketing Date: | 20090930 |
Package NDC: | 67457-176-10 |
Package Description: | 1 VIAL in 1 CARTON (67457-176-10) > 10 mL in 1 VIAL |
NDC Code | 67457-176-10 |
Proprietary Name | Sotalol hydrochloride |
Package Description | 1 VIAL in 1 CARTON (67457-176-10) > 10 mL in 1 VIAL |
Product NDC | 67457-176 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Sotalol hydrochloride |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20090930 |
Marketing Category Name | NDA |
Labeler Name | Bioniche Pharma USA LLC |
Substance Name | SOTALOL HYDROCHLORIDE |
Strength Number | 15 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Antiarrhythmic [EPC] |