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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077616
Company: AUROBINDO PHARMA USA

Products on ANDA 077616

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077616

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2007	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
08/25/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077616

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	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 LLC
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	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	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 LLC
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	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	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 LLC
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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