← FDA DRUG APPROVALS

FDA NDA · NDA022203

ASTEPRO

Sponsor: VIATRIS

APPLICATION
NDA022203
TYPE
NDA
ORIGINAL APPROVAL
2008-10-15
LATEST ACTION
2021-06-28
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

ASTEPRO · ReferenceDiscontinued
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL
ASTEPRODiscontinued
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2021-06-28Labeling · Supplement 18 · standard — Label ↗AP
2018-09-06Labeling · Supplement 15 · standard — Label ↗AP
2015-09-25Manufacturing (CMC) · Supplement 14 · standardAP
2015-02-20Efficacy · Supplement 10 · priority — Label ↗AP
2015-02-20Efficacy · Supplement 11 · priority — Label ↗AP
2014-03-13Manufacturing (CMC) · Supplement 9 · standardAP
2013-08-30Efficacy · Supplement 8 · standard — Label ↗AP
2011-01-19Labeling · Supplement 6 · unknown — Letter ↗AP
2009-08-31Labeling · Supplement 3 · standard — Label ↗AP
2008-10-15Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗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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