Details for New Drug Application (NDA): 020818
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The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-005 | Apr 28, 2006 | 6,294,197*PED | ⤷ Subscribe |
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-004 | Apr 28, 2006 | 5,399,578*PED | ⤷ Subscribe |
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-005 | Apr 28, 2006 | 5,399,578*PED | ⤷ Subscribe |
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-001 | Mar 6, 1998 | 5,399,578*PED | ⤷ Subscribe |
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-003 | Jan 17, 2002 | 5,399,578*PED | ⤷ Subscribe |
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-004 | Apr 28, 2006 | 6,294,197*PED | ⤷ Subscribe |
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