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Details for New Drug Application (NDA): 202331

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

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. 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; chlorthalidone profile page.

Summary for NDA: 202331

Tradename:
EDARBYCLOR
Applicant:
Arbor Pharms Llc
Ingredient:
azilsartan kamedoxomil; chlorthalidone
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 202331

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 Arbor Pharmaceuticals 60631-412 60631-412-07 5 BLISTER PACK in 1 TRAY (60631-412-07) > 7 TABLET in 1 BLISTER PACK
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL 202331 NDA Arbor Pharmaceuticals 60631-412 60631-412-30 30 TABLET in 1 BOTTLE (60631-412-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG MEDOXOMIL;12.5MG
Approval Date:Dec 20, 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?
Patent:9,169,238Patent Expiration:Feb 4, 2030Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202331

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 20115,583,141► subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 20115,583,141► subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 20115,736,555► subscribe
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