Details for New Drug Application (NDA): 200175
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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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | 200175-001 | 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 |
Cosette | TRIBENZOR | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 200175-002 | Jul 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
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