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FDA NDA · NDA021036

RELENZA

zanamivir

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA021036
TYPE
NDA
ORIGINAL APPROVAL
1999-07-26
LATEST ACTION
2023-10-24
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

RELENZA · ReferencePrescription
ZANAMIVIR 5MG · POWDER · INHALATION

Approval history

2023-10-24Labeling · Supplement 34 · standard — Label ↗AP
2021-10-19Labeling · Supplement 32 · standard — Label ↗AP
2018-06-21Labeling · Supplement 30 · standard — Label ↗AP
2016-07-21Manufacturing (CMC) · Supplement 29 · priorityAP
2013-02-15Manufacturing (CMC) · Supplement 28 · priorityAP
2011-12-20Labeling · Supplement 27 · standard — Label ↗AP
2010-12-09Labeling · Supplement 25 · standard — Label ↗AP
2010-05-04Labeling · Supplement 24 · unknown — Letter ↗AP
2010-03-24Labeling · Supplement 19 · unknown — Letter ↗AP
2009-05-08Manufacturing (CMC) · Supplement 18 · priority — Letter ↗AP
2008-10-02Labeling · Supplement 17 · standard — Label ↗AP
2008-02-21Labeling · Supplement 16 · standard — Label ↗AP
2007-12-13Manufacturing (CMC) · Supplement 15 · priority — Letter ↗AP
2007-09-07Labeling · Supplement 12 · standard — Label ↗AP
2007-06-27Manufacturing (CMC) · Supplement 14 · priority — Letter ↗AP
2007-03-09Labeling · Supplement 13 · standard — Letter ↗AP
2006-11-22Labeling · Supplement 10 · priority — Letter ↗AP
2006-03-29Efficacy · Supplement 8 · priority — Label ↗AP
2006-03-29Efficacy · Supplement 9 · priorityAP
2004-03-25Labeling · Supplement 7 · priority — Letter ↗AP
2003-08-06Labeling · Supplement 6 · standard — Letter ↗AP
2003-08-05Labeling · Supplement 5 · standard — Letter ↗AP
2001-05-18Manufacturing (CMC) · Supplement 3 · priorityAP
2001-04-27Labeling · Supplement 4 · standard — Label ↗AP
2000-04-26Efficacy · Supplement 1 · priority — Review ↗AP
1999-07-26Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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