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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 200796

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NDA 200796 describes EDARBI, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the EDARBI profile page.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.

Summary for 200796

Tradename:	EDARBI
Applicant:	Azurity
Ingredient:	azilsartan kamedoxomil
Patents:	3
Formulation / Manufacturing:	see details

Pharmacology for NDA: 200796

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

Suppliers and Packaging for NDA: 200796

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040	60631-040-30	30 TABLET in 1 BOTTLE (60631-040-30)
EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040	60631-040-77	7 TABLET in 1 BOTTLE (60631-040-77)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG MEDOXOMIL
Approval Date:	Feb 25, 2011	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	May 22, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Jan 7, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPERTENSION
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 200796

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Try a Trial	⤷ Try a Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Try a Trial	⤷ Try a Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Try a Trial	⤷ Try a Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Try a Trial	⤷ Try a Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Try a Trial	⤷ Try a Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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