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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021742
Company: ALLERGAN

Products on NDA 021742

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021742

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2007	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021742s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021742s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2023	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021742s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021742Orig1s028ltr.pdf
11/30/2017	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021742Orig1s022ltr.pdf
04/20/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/27/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/30/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/20/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/19/2012	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/14/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021742s013ltr.pdf
02/19/2010	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021742s007ltr.pdf
10/08/2008	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for NDA 021742

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021742s028lbl.pdf
11/30/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf
12/14/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf
02/19/2010	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf

Therapeutic Equivalents for NDA 021742

BYSTOLIC

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021742	ALLERGAN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	203659	ANI PHARMS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	211053	AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	208717	CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	203821	GLENMARK PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	203825	HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	203828	INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	212661	MACLEODS PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	216172	MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	217397	MSN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	212682	PRINSTON INC
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	216568	REGCON HOLDINGS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	212917	REYOUNG
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	203966	TORRENT
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	213830	UNICHEM

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021742	ALLERGAN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203659	ANI PHARMS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	211053	AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	208717	CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203821	GLENMARK PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203825	HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203828	INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	212661	MACLEODS PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	216172	MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	217397	MSN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	212682	PRINSTON INC
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	216568	REGCON HOLDINGS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	212917	REYOUNG
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203966	TORRENT
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	213830	UNICHEM

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	021742	ALLERGAN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203659	ANI PHARMS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	211053	AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	208717	CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203821	GLENMARK PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203825	HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203828	INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	212661	MACLEODS PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	216172	MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	217397	MSN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	212682	PRINSTON INC
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	216568	REGCON HOLDINGS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	212917	REYOUNG
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203966	TORRENT
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	213830	UNICHEM

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	Yes	AB	021742	ALLERGAN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203659	ANI PHARMS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	211053	AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	208717	CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203821	GLENMARK PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203825	HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203828	INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	212661	MACLEODS PHARMS LTD
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	216172	MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	217397	MSN
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	212682	PRINSTON INC
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	216568	REGCON HOLDINGS
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	212917	REYOUNG
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203966	TORRENT
NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	213830	UNICHEM

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