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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 200175


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NDA 200175 describes TRIBENZOR, which is a drug marketed by Cosette and is included in one NDA. It is available from three 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. Seven 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 Cosette Pharmaceuticals, Inc. 0713-0874 0713-0874-30 30 TABLET, FILM COATED in 1 BOTTLE (0713-0874-30)
TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175 NDA Cosette Pharmaceuticals, Inc. 0713-0875 0713-0875-30 30 TABLET, FILM COATED in 1 BOTTLE (0713-0875-30)

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175-001 Jul 23, 2010 ⤷  Try a Trial ⤷  Try a Trial
Cosette TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175-005 Jul 23, 2010 ⤷  Try a Trial ⤷  Try a Trial
Cosette TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175-004 Jul 23, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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