Details for New Drug Application (NDA): 020387
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The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 020387
Tradename: | HYZAAR |
Applicant: | Organon |
Ingredient: | hydrochlorothiazide; losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 020387
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 020387
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-139 | 78206-139-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-139-01) |
HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-139 | 78206-139-02 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-139-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;50MG | ||||
Approval Date: | Apr 28, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Nov 10, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;100MG | ||||
Approval Date: | Oct 20, 2005 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020387
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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