Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206302
Company: ABBVIE

Products on NDA 206302

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BYVALSON	NEBIVOLOL HYDROCHLORIDE; VALSARTAN	EQ 5MG BASE;80MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206302

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2016	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206302s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206302Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206302Orig1ByvalsonTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2023	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206302s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206302Orig1s001ltr.pdf

Labels for NDA 206302

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2023	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206302s001lbl.pdf
06/16/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206302s001lbl.pdf
06/03/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206302s000lbl.pdf