← FDA DRUG APPROVALS

FDA NDA · NDA020114

ASTELIN

Sponsor: RISING

APPLICATION
NDA020114
TYPE
NDA
ORIGINAL APPROVAL
1996-11-01
LATEST ACTION
2018-09-06
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

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AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2018-09-06Labeling · Supplement 28 · standard — Label ↗AP
2014-10-23Labeling · Supplement 26 · standard — Letter ↗AP
2014-03-13Manufacturing (CMC) · Supplement 25 · standardAP
2012-01-20Labeling · Supplement 23 · standard — Letter ↗AP
2007-08-10Labeling · Supplement 17 · standard — Letter ↗AP
2006-02-17Efficacy · Supplement 14 · unknownAP
2001-06-27Manufacturing (CMC) · Supplement 7 · standardAP
2000-10-13Manufacturing (CMC) · Supplement 3 · standardAP
2000-09-15Efficacy · Supplement 6 · standard — Review ↗AP
2000-05-30Efficacy · Supplement 5 · unknown — Letter ↗AP
1999-02-16Labeling · Supplement 2 · standardAP
1997-09-29Labeling · Supplement 1 · standardAP
1996-11-01Type 1 - New Molecular Entity · Original · standard — 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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