Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075563
Company: OXFORD PHARMS

Products on ANDA 075563

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
02/28/2023	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
10/29/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/28/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/28/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/01/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075563

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	LEGACY PHARMA
BETAPACE AF	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	Yes	AB	021151	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
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	077616	AUROBINDO PHARMA USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	077070	EPIC PHARMA LLC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	207428	REGCON HOLDINGS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	207429	REGCON HOLDINGS
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	LEGACY PHARMA
BETAPACE AF	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	Yes	AB	021151	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
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	077616	AUROBINDO PHARMA USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	077070	EPIC PHARMA LLC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	207428	REGCON HOLDINGS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	207429	REGCON HOLDINGS
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	LEGACY PHARMA
BETAPACE AF	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	Yes	AB	021151	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
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	077616	AUROBINDO PHARMA USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	077070	EPIC PHARMA LLC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	207428	REGCON HOLDINGS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	207429	REGCON HOLDINGS
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	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
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