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Last Updated: November 7, 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
Pharmacology for NDA: 200796
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:RXDosage:TABLET;ORALStrengthEQ 40MG MEDOXOMIL
Approval Date:Feb 25, 2011TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 22, 2025Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION
Patent:⤷  Sign UpPatent Expiration:Mar 26, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 200796

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

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