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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075500
Company: AIPING PHARM INC

Products on ANDA 075500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SORINE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	AB	No	No
SORINE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	AB	No	No
SORINE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	AB	No	No
SORINE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75500ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/13/2003	SUPPL-2	Labeling		Label is not available on this site.
12/19/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075500

SORINE

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; 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

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

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