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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019865
Company: COVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAPACE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB Yes No
BETAPACE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription AB Yes Yes
BETAPACE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription AB Yes No
BETAPACE SOTALOL HYDROCHLORIDE 320MG TABLET;ORAL Discontinued None No No
BETAPACE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/03/2021 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf
05/10/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf
08/17/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf
02/03/2011 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf
10/01/2001 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf
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