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FDA NDA · NDA020409

NASAREL

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA020409
TYPE
NDA
ORIGINAL APPROVAL
1995-03-08
LATEST ACTION
2008-03-17
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

NASARELDiscontinued
FLUNISOLIDE 0.029MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2008-03-17Manufacturing (CMC) · Supplement 22 · standard — Letter ↗AP
2002-08-23Manufacturing (CMC) · Supplement 13 · standardAP
2002-05-09Labeling · Supplement 11 · standard — Letter ↗AP
2002-05-09Labeling · Supplement 5 · standard — Letter ↗AP
2001-03-27Labeling · Supplement 6 · standard — Letter ↗AP
2000-09-15Manufacturing (CMC) · Supplement 8 · standardAP
2000-06-29Manufacturing (CMC) · Supplement 9 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 4 · standardAP
1998-04-21Manufacturing (CMC) · Supplement 2 · standardAP
1996-10-01Manufacturing (CMC) · Supplement 1 · standardAP
1995-03-08Type 3 - New Dosage Form · Original · standardAP
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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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