Details for New Drug Application (NDA): 021532
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The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 021532
Tradename: | BENICAR HCT |
Applicant: | Cosette |
Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
Patents: | 0 |
Pharmacology for NDA: 021532
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 021532
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0863 | 0713-0863-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0863-30) |
BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0864 | 0713-0864-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
Approval Date: | Jun 5, 2003 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
Approval Date: | Jun 5, 2003 | TE: | AB | RLD: | Yes |
Profile for product number 005
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
Approval Date: | Jun 5, 2003 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021532
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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