Details for New Drug Application (NDA): 020387
✉ Email this page to a colleague
NDA 020387 describes HYZAAR, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. Additional details are available on the HYZAAR profile page.
The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Twenty-eight 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
Complete Access Available with Subscription
