Betapace AF - sotalol hydrochloride
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Field |
Value |
NDC Code: |
50419-116 |
Proprietary Name: |
Betapace AF |
Suffix: |
|
Non-Proprietary Name: |
sotalol hydrochloride |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
22-02-2000 |
Category Name: |
NDA |
Application Number: |
NDA021151 |
Labeler: |
BAYER HEALTHCARE PHARMACEUTICALS INC. |
Substance Name: |
SOTALOL HYDROCHLORIDE |
Active Numerator Strength: |
160 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Antiarrhythmic [EPC] |
DEA Schedule: |
|