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Last Updated: October 7, 2024

Details for New Drug Application (NDA): 022314


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NDA 022314 describes EXFORGE 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 EXFORGE HCT profile page.

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
Pharmacology for NDA: 022314
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;25MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;12.5MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes

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 022314-004 Apr 30, 2009 ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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