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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021990


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NDA 021990 describes EXFORGE, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the EXFORGE profile page.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 021990
Tradename:EXFORGE
Applicant:Novartis
Ingredient:amlodipine besylate; valsartan
Patents:0
Suppliers and Packaging for NDA: 021990
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0488 0078-0488-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)
EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0489 0078-0489-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0489-15)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;320MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes

Expired US Patents for NDA 021990

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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