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FDA NDA · NDA021861

PATANASE

Sponsor: NOVARTIS

APPLICATION
NDA021861
TYPE
NDA
ORIGINAL APPROVAL
2008-04-15
LATEST ACTION
2021-03-04
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

PATANASE · ReferenceDiscontinued
OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2021-03-04Labeling · Supplement 15 · standard — Letter ↗AP
2016-07-27Manufacturing (CMC) · Supplement 12 · standardAP
2015-10-27Labeling · Supplement 11 · standard — Letter ↗AP
2012-02-22Labeling · Supplement 9 · standard — Letter ↗AP
2010-03-31Efficacy · Supplement 8 · standard — Letter ↗AP
2009-12-01Efficacy · Supplement 2 · priority — Label ↗AP
2009-06-17Efficacy · Supplement 1 · unknownAP
2008-04-15Type 3 - New Dosage Form · 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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