Visitor Monitoring Drug Details: BETAPACE
 
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Drug Details

Drug Name: BETAPACE
FDA Application No: (NDA) 019865
Active Ingredient(s): SOTALOL HYDROCHLORIDE
Company: BAYER HLTHC
Original Approval or Tentative Approval Date: October 30, 1992
Chemical Type: 1 New molecular entity (NME)
Review Classification: P Priority 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 SOTALOL HYDROCHLORIDE80MGTABLET; ORAL Prescription No AB1
BETAPACE SOTALOL HYDROCHLORIDE160MGTABLET; ORAL Prescription Yes AB1
BETAPACE SOTALOL HYDROCHLORIDE240MGTABLET; ORAL Prescription No AB1
BETAPACE SOTALOL HYDROCHLORIDE320MGTABLET; ORAL Discontinued No None
BETAPACE SOTALOL HYDROCHLORIDE120MGTABLET; ORAL Prescription No AB1


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