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 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.
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 | 200175-005 | Jul 23, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Cosette | TRIBENZOR | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 200175-001 | Jul 23, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Cosette | TRIBENZOR | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 200175-004 | Jul 23, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Cosette | TRIBENZOR | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 200175-003 | Jul 23, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Cosette | TRIBENZOR | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 200175-002 | Jul 23, 2010 | ⤷ Subscribe | ⤷ Subscribe |
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