Visitor Monitoring Drug Details: BETAPACE AF
 
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Drug Details

Drug Name: BETAPACE AF
FDA Application No: (NDA) 021151
Active Ingredient(s): SOTALOL HYDROCHLORIDE
Company: BAYER HLTHC
Original Approval or Tentative Approval Date: February 22, 2000
Chemical Type: 6 New indication
Review Classification: S Standard review drug
O Orphan drug
 
Therapeutic Equivalents Label Information
Approval History, Letters, Reviews and Related Documents
 
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Drug NameSort imageActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE Code
BETAPACE AF SOTALOL HYDROCHLORIDE80MGTABLET; ORAL Prescription No AB2
BETAPACE AF SOTALOL HYDROCHLORIDE120MGTABLET; ORAL Prescription No AB2
BETAPACE AF SOTALOL HYDROCHLORIDE160MGTABLET; ORAL Prescription Yes AB2
BETAPACE AF SOTALOL HYDROCHLORIDE100MGTABLET; ORAL Discontinued No None
BETAPACE AF SOTALOL HYDROCHLORIDE40MGTABLET; ORAL Discontinued No None
BETAPACE AF SOTALOL HYDROCHLORIDE60MGTABLET; ORAL Discontinued No None


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