Details for New Drug Application (NDA): 200175

✉ Email this page to a colleague

NDA 200175 describes TRIBENZOR, which is a drug marketed by Cosette and is included in one NDA. It is available from one supplier. 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for 200175

Tradename:	TRIBENZOR
Applicant:	Cosette
Ingredient:	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
Patents:	0

Pharmacology for NDA: 200175

Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;12.5MG;20MG
Approval Date:	Jul 23, 2010	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;12.5MG;40MG
Approval Date:	Jul 23, 2010	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;25MG;40MG
Approval Date:	Jul 23, 2010	TE:	AB	RLD:	Yes

Expired US Patents for NDA 200175

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-004	Jul 23, 2010	⤷ Sign Up	⤷ Sign Up
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010	⤷ Sign Up	⤷ Sign Up
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.