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Approved Drug Products containing Indacaterol Maleate listed in the FDA Orange Book. Original Data : FDA Website

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01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

INDACATEROL MALEATE

Brand Name : ARCAPTA NEOHALER

Dosage Form : POWDER;INHALATION

Dosage Strength : EQ 75MCG BASE

Approval Date : 2011-07-01

Application Number : 22383

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

GLYCOPYRROLATE; INDACATEROL MALEATE

Brand Name : UTIBRON

Dosage Form : POWDER;INHALATION

Dosage Strength : 15.6MCG/INH;27.5MCG/INH

Approval Date : 2015-10-29

Application Number : 207930

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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