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Generated: September 26, 2018

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Details for New Drug Application (NDA): 200175

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NDA 200175 describes TRIBENZOR, which is a drug marketed by Daiichi Sankyo and is included in one NDA. It is available from two suppliers. Additional details are available on the TRIBENZOR profile page.

The generic ingredient in TRIBENZOR is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 200175
Pharmacology for NDA: 200175
Suppliers and Packaging for NDA: 200175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175 NDA Sun Pharmaceutical Industries, Inc. 57664-796 57664-796-83 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-796-83)
TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175 NDA Sun Pharmaceutical Industries, Inc. 57664-796 57664-796-99 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-796-99)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;20MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;40MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;25MG;40MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes

Expired US Patents for NDA 200175

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