Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075429
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Prescription AB No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Prescription AB 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
05/01/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75429ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75429ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/04/2021 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/24/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/04/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/28/2011 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/11/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/26/2006 SUPPL-11 Labeling

Label is not available on this site.

12/03/2002 SUPPL-2 Labeling

Label is not available on this site.

10/13/2000 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/01/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol%20Hydrochloride_prntlbl.pdf

SOTALOL HYDROCHLORIDE

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

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
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

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