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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021151
Company: LEGACY PHARMA

Products on NDA 021151

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021151

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.html

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.

Labels for NDA 021151

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

Therapeutic Equivalents for NDA 021151

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	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

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