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Details for New Drug Application (NDA): 022314
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The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 022314
Tradename: | EXFORGE HCT |
Applicant: | Novartis |
Ingredient: | amlodipine besylate; hydrochlorothiazide; valsartan |
Patents: | 2 |
Pharmacology for NDA: 022314
Mechanism of Action | Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 022314
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314 | NDA | Novartis Pharmaceuticals Corporation | 0078-0559 | 0078-0559-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0559-15) |
EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314 | NDA | Novartis Pharmaceuticals Corporation | 0078-0560 | 0078-0560-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0560-15) |
Paragraph IV (Patent) Challenges for 022314
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
EXFORGE HCT | TABLET;ORAL | amlodipine besylate; hydrochlorothiazide; valsartan | 022314 | 2009-10-22 |
EXFORGE HCT | TABLET;ORAL | amlodipine besylate; hydrochlorothiazide; valsartan | 022314 | 2009-09-14 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;160MG | ||||
Approval Date: | Apr 30, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | May 16, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Nov 16, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;25MG;160MG | ||||
Approval Date: | Apr 30, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | May 16, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022314
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-005 | Apr 30, 2009 | Start Trial | Start Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | Start Trial | Start Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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