Details for New Drug Application (NDA): 020818
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NDA 020818 describes DIOVAN HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the DIOVAN HCT profile page.
The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 020818
| Tradename: | DIOVAN HCT |
| Applicant: | Novartis |
| Ingredient: | hydrochlorothiazide; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 020818
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 020818
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818 | NDA | Novartis Pharmaceuticals Corporation | 0078-0314 | 0078-0314-34 | 90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34) |
| DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818 | NDA | Novartis Pharmaceuticals Corporation | 0078-0315 | 0078-0315-34 | 90 TABLET, FILM COATED in 1 BOTTLE (0078-0315-34) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
| Approval Date: | Mar 6, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;160MG | ||||
| Approval Date: | Mar 6, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;160MG | ||||
| Approval Date: | Jan 17, 2002 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020818
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