Edarbyclor

Treats hypertension. NDA 202331, held by Azurity. Azilsartan Kamedoxomil; Chlorthalidone.

As of Nov 14, 2026, NDA 202331 (Edarbyclor), held by Azurity, was first approved by FDA on Dec 20, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2011
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 20, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


EdarbyclorEQ 40MG MEDOXOMIL;12.5MG · tablet;oral	Azilsartan Kamedoxomil; Chlorthalidone	RxReference drug
EdarbyclorEQ 40MG MEDOXOMIL;25MG · tablet;oral	Azilsartan Kamedoxomil; Chlorthalidone	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Mar 9, 2020	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 11Labeling · Standard review	Approved	Letter
Nov 18, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 16, 2015	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 23, 2014	Supplement 6Labeling · Standard review	Approved	Label Letter
Apr 18, 2014	Supplement 5Labeling · Standard review	Approved	Letter
Oct 4, 2012	Supplement 2Labeling	Approved	Label Letter
Apr 10, 2012	Supplement 1Labeling	Approved	None posted
Dec 20, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 202331
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters