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FDA NDA · NDA022383

ARCAPTA NEOHALER

Sponsor: NOVARTIS

APPLICATION
NDA022383
TYPE
NDA
ORIGINAL APPROVAL
2011-07-01
LATEST ACTION
2021-07-30
ROUTE
INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

ARCAPTA NEOHALER · ReferenceDiscontinued
INDACATEROL MALEATE EQ 75MCG BASE · POWDER · INHALATION

Approval history

2021-07-30Labeling · Supplement 9 · standard — Letter ↗AP
2021-07-30Labeling · Supplement 10 · standard — Letter ↗AP
2019-05-29Labeling · Supplement 7 · standard — Label ↗AP
2013-02-25Manufacturing (CMC) · Supplement 3 · standardAP
2012-12-18REMS · Supplement 5 — Letter ↗AP
2012-12-18Labeling · Supplement 4 · standard — Letter ↗AP
2012-09-26Labeling · Supplement 2 · unknown — Label ↗AP
2011-07-01Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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