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Details for New Drug Application (NDA): 022383

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NDA 022383 describes ARCAPTA NEOHALER, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ARCAPTA NEOHALER profile page.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. One supplier is listed for this compound. Additional details are available on the indacaterol maleate profile page.

Summary for NDA: 022383

Tradename:
ARCAPTA NEOHALER
Applicant:
Novartis
Ingredient:
indacaterol maleate
Patents:5

Pharmacology for NDA: 022383

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 022383

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION 022383 NDA Novartis Pharmaceuticals Corporation 0078-0619 0078-0619-15 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0619-15) > 1 CAPSULE in 1 BLISTER PACK (0078-0619-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 75MCG BASE
Approval Date:Jul 1, 2011TE:RLD:Yes
Patent:8,479,730Patent Expiration:Oct 11, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,796,307Patent Expiration:Jun 2, 2020Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jul 1, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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