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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200796
Company: AZURITY

Products on NDA 200796

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EDARBI	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET;ORAL	Prescription	AB	Yes	No
EDARBI	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200796

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200796sOrig1s000_Edarbi_TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200796s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200796Orig1s013ltr.pdf
03/06/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200796s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200796Orig1s012ltr.pdf
10/24/2016	SUPPL-9	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200796Orig1s009ltr.pdf
03/24/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/23/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s006ltr.pdf
04/18/2014	SUPPL-5	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331Orig1s005ltr.pdf
07/29/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/04/2012	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200796Orig1s003ltr_replacement.pdf
12/14/2011	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s002ltr.pdf
04/12/2011	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s001ltr.pdf

Labels for NDA 200796

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200796s013lbl.pdf
03/06/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200796s012lbl.pdf
07/23/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf
10/04/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf
12/14/2011	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf
04/12/2011	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s001lbl.pdf
02/25/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf

Therapeutic Equivalents for NDA 200796

EDARBI

TABLET;ORAL; EQ 40MG MEDOXOMIL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDARBI	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET;ORAL	Prescription	Yes	AB	200796	AZURITY

TABLET;ORAL; EQ 80MG MEDOXOMIL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDARBI	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET;ORAL	Prescription	Yes	AB	200796	AZURITY

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