Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021151
Company: COVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAPACE AF SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB Yes No
BETAPACE AF SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB Yes No
BETAPACE AF SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription AB Yes Yes
BETAPACE AF SOTALOL HYDROCHLORIDE 100MG TABLET;ORAL Discontinued None No No
BETAPACE AF SOTALOL HYDROCHLORIDE 40MG TABLET;ORAL Discontinued None No No
BETAPACE AF SOTALOL HYDROCHLORIDE 60MG TABLET;ORAL Discontinued None No 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
02/22/2000 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21151ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021151_s000_BetapaceAFTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2011 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s010ltr.pdf
02/03/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s009ltr.pdf
04/02/2003 SUPPL-5 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs005ltr.pdf
03/14/2003 SUPPL-4 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs004ltr.pdf
10/01/2001 SUPPL-3 Labeling

Label is not available on this site.

11/22/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf
02/03/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf
02/22/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf

BETAPACE AF

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
BETAPACE AF SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB 021151 COVIS
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 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG 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
BETAPACE AF SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 021151 COVIS
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 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG 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
BETAPACE AF SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription Yes AB 021151 COVIS
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 075563 OXFORD PHARMS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription No AB 075429 TEVA

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