Product NDC: | 0378-5125 |
Proprietary Name: | Sotalol Hydrochloride |
Non Proprietary Name: | sotalol hydrochloride |
Active Ingredient(s): | 160 mg/1 & nbsp; sotalol hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-5125 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA077616 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120904 |
Package NDC: | 0378-5125-01 |
Package Description: | 100 TABLET in 1 BOTTLE, PLASTIC (0378-5125-01) |
NDC Code | 0378-5125-01 |
Proprietary Name | Sotalol Hydrochloride |
Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (0378-5125-01) |
Product NDC | 0378-5125 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | sotalol hydrochloride |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20120904 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | SOTALOL HYDROCHLORIDE |
Strength Number | 160 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Antiarrhythmic [EPC] |