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Last Updated: November 14, 2024

Details for New Drug Application (NDA): 206665


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NDA 206665 describes ALISKIREN HEMIFUMARATE, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the ALISKIREN HEMIFUMARATE profile page.

The generic ingredient in ALISKIREN HEMIFUMARATE is aliskiren hemifumarate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate profile page.
Summary for 206665
Tradename:ALISKIREN HEMIFUMARATE
Applicant:Endo Operations
Ingredient:aliskiren hemifumarate
Patents:0
Pharmacology for NDA: 206665
Mechanism of ActionRenin Inhibitors
Suppliers and Packaging for NDA: 206665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALISKIREN HEMIFUMARATE aliskiren hemifumarate TABLET;ORAL 206665 ANDA Endo USA, Inc. 49884-424 49884-424-11 30 TABLET, FILM COATED in 1 BOTTLE (49884-424-11)
ALISKIREN HEMIFUMARATE aliskiren hemifumarate TABLET;ORAL 206665 ANDA Endo USA, Inc. 49884-425 49884-425-11 30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 22, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Mar 22, 2019TE:ABRLD:No

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