Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019865
Company: COVIS PHARMA BV
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1992 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/2016 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019865Orig1s021ltr.pdf
08/17/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s020ltr.pdf
02/03/2011 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s019ltr.pdf
07/26/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-11 Labeling

Label is not available on this site.

10/01/2001 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865s10_Betapace.cfm
04/09/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/23/1999 SUPPL-8 Labeling

Label is not available on this site.

12/04/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/26/1995 SUPPL-5 Labeling

Label is not available on this site.

04/20/1994 SUPPL-4 Labeling

Label is not available on this site.

09/06/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/20/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/13/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

BETAPACE

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB 019865 COVIS PHARMA BV
BETAPACE AF SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB 021151 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 076140 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 076214 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 207428 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 207429 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 077070 EPIC PHARMA INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 077616 MYLAN
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 075429 TEVA

TABLET;ORAL; 160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription Yes AB 019865 COVIS PHARMA BV
BETAPACE AF SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription Yes AB 021151 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 076140 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 076214 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 207428 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 207429 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 077070 EPIC PHARMA INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 077616 MYLAN
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 075429 TEVA

TABLET;ORAL; 240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription Yes AB 019865 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB 076140 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription No AB 075429 TEVA

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAPACE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 019865 COVIS PHARMA BV
BETAPACE AF SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 021151 COVIS PHARMA BV
SORINE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 075500 UPSHER SMITH LABS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 076140 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 076214 APOTEX
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 207428 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 207429 BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 077070 EPIC PHARMA INC
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 077616 MYLAN
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 075429 TEVA

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