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Details for New Drug Application (NDA): 200796

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NDA 200796 describes EDARBI, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from two suppliers. 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 five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.

Summary for NDA: 200796

Arbor Pharms Llc
azilsartan kamedoxomil
Formulation / Manufacturing:see details

Pharmacology for NDA: 200796

Suppliers and Packaging for NDA: 200796

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
azilsartan kamedoxomil
TABLET;ORAL 200796 NDA Arbor Pharmaceuticals 60631-040 60631-040-07 5 BLISTER PACK in 1 TRAY (60631-040-07) > 7 TABLET in 1 BLISTER PACK
azilsartan kamedoxomil
TABLET;ORAL 200796 NDA Arbor Pharmaceuticals 60631-040 60631-040-30 30 TABLET in 1 BOTTLE (60631-040-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG MEDOXOMIL
Approval Date:Feb 25, 2011TE:RLD:No
Patent:7,157,584Patent Expiration:May 22, 2025Product Flag?Substance Flag?YDelist Request?
Patent:9,066,936Patent Expiration:Mar 26, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Feb 25, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired Orange Book Patents for NDA: 200796

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,958,961<disabled>
Arbor Pharms Llc
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,583,141<disabled>
Arbor Pharms Llc
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 20115,583,141<disabled>
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