Details for New Drug Application (NDA): 202331

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NDA 202331 describes EDARBYCLOR, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the EDARBYCLOR profile page.

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.

Summary for 202331

Tradename:	EDARBYCLOR
Applicant:	Azurity
Ingredient:	azilsartan kamedoxomil; chlorthalidone
Patents:	5

Pharmacology for NDA: 202331

Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure Increased Diuresis

Suppliers and Packaging for NDA: 202331

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-412	60631-412-30	30 TABLET in 1 BOTTLE (60631-412-30)
EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-425	60631-425-30	30 TABLET in 1 BOTTLE (60631-425-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG MEDOXOMIL;12.5MG
Approval Date:	Dec 20, 2011	TE:	AB	RLD:	Yes
Patent:	7,157,584	Patent Expiration:	May 22, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	7,572,920	Patent Expiration:	Jan 7, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPERTENSION
Patent:	9,066,936	Patent Expiration:	Mar 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202331

Show entries

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	5,583,141	⤷ Try for Free
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	7,572,920	⤷ Try for Free
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,583,141	⤷ Try for Free
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	5,736,555	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Showing 1 to 4 of 4 entries

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