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FDA NDA · NDA020121

FLONASE

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020121
TYPE
NDA
ORIGINAL APPROVAL
1994-10-19
LATEST ACTION
2019-01-07
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

FLONASE · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2019-01-07Labeling · Supplement 45 · standard — Label ↗AP
2015-01-23Labeling · Supplement 44 · standard — Label ↗AP
2014-06-17Manufacturing (CMC) · Supplement 43 · standardAP
2014-06-17Manufacturing (CMC) · Supplement 42 · standardAP
2013-06-19Manufacturing (CMC) · Supplement 41 · standardAP
2004-03-26Labeling · Supplement 30 · standard — Label ↗AP
2003-05-01Efficacy · Supplement 28 · standard — Letter ↗AP
2002-05-23Efficacy · Supplement 23 · standard — Letter ↗AP
2002-05-09Labeling · Supplement 13 · standard — Letter ↗AP
2002-05-09Labeling · Supplement 11 · standard — Letter ↗AP
2002-05-09Labeling · Supplement 20 · standard — Letter ↗AP
2002-05-07Manufacturing (CMC) · Supplement 26 · standardAP
2002-03-04Manufacturing (CMC) · Supplement 25 · standardAP
2002-02-19Manufacturing (CMC) · Supplement 24 · standardAP
2001-08-03Manufacturing (CMC) · Supplement 17 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 22 · standardAP
2001-06-25Manufacturing (CMC) · Supplement 21 · standardAP
2000-09-26Manufacturing (CMC) · Supplement 8 · standardAP
2000-06-20Manufacturing (CMC) · Supplement 16 · standardAP
2000-05-17Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 12 · standardAP
1998-12-11Efficacy · Supplement 9 · standard — Review ↗AP
1998-10-01Labeling · Supplement 10 · standardAP
1998-02-18Manufacturing (CMC) · Supplement 6 · standardAP
1997-10-31Efficacy · Supplement 5 · unknown — Review ↗AP
1996-12-12Labeling · Supplement 4 · standardAP
1996-03-27Labeling · Supplement 3 · standardAP
1995-08-01Manufacturing (CMC) · Supplement 2 · standardAP
1994-10-19Type 3 - New Dosage Form · Original · standard — Pediatric Clinical Pharmacology 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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