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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 four suppliers. There are four patents protecting this drug and six Paragraph IV challenges. Additional details are available on the EXFORGE profile page.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are forty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for NDA: 021990

Tradename:
EXFORGE
Applicant:
Novartis
Ingredient:
amlodipine besylate; valsartan
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021990

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)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Jun 20, 2007TE:ABRLD:No
Patent:6,294,197*PEDPatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,395,728Patent Expiration:Jul 8, 2019Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes
Patent:6,294,197*PEDPatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021990

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-002Jun 20, 20075,399,578*PED► subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-003Jun 20, 20075,399,578*PED► subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 20075,399,578*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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