Betapace - Sotalol Hydrochloride
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Field |
Value |
NDC Code: |
50419-109 |
Proprietary Name: |
Betapace |
Suffix: |
|
Non-Proprietary Name: |
Sotalol Hydrochloride |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
30-10-1992 |
Category Name: |
NDA |
Application Number: |
NDA019865 |
Labeler: |
BAYER HEALTHCARE PHARMACEUTICALS INC. |
Substance Name: |
SOTALOL HYDROCHLORIDE |
Active Numerator Strength: |
120 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Antiarrhythmic [EPC] |
DEA Schedule: |
|