An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 202331
Company: AZURITY

Summary Review

Products on NDA 202331

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EDARBYCLOR	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;12.5MG	TABLET;ORAL	Prescription	None	Yes	No
EDARBYCLOR	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;25MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202331

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2011	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202331lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202331s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202331_edarbyclor_toc_.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202331Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202331s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202331Orig1s016ltr.pdf
10/24/2016	SUPPL-11	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202331Orig1s011ltr.pdf
11/18/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/16/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202331s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202331Orig1s007ltr.pdf
07/23/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202331s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202331Orig1s006ltr.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
10/04/2012	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202331s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202331Orig1s002ltr_replacement.pdf
04/10/2012	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 202331

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202331s016lbl.pdf
04/16/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202331s007lbl.pdf
07/23/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202331s006lbl.pdf
10/04/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202331s002lbl.pdf
12/20/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202331lbl.pdf

Top