← FDA DRUG APPROVALS

FDA NDA · NDA050784

ZITHROMAX

azithromycin dihydrate

Sponsor: PFIZER

APPLICATION
NDA050784
TYPE
NDA
ORIGINAL APPROVAL
2002-05-24
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZITHROMAX · ReferencePrescription
AZITHROMYCIN EQ 500MG BASE · TABLET · ORAL

Approval history

2026-07-13Labeling · Supplement 40 · standard — Label ↗AP
2021-11-22Labeling · Supplement 37 · standard — Letter ↗AP
2019-04-24Labeling · Supplement 34 · standard — Letter ↗AP
2017-03-30Labeling · Supplement 30 · standard — Label ↗AP
2017-02-10Labeling · Supplement 28 · standard — Label ↗AP
2016-05-23Labeling · Supplement 27 · standard — Label ↗AP
2014-06-07Labeling · Supplement 21 · standard — Label ↗AP
2013-02-19Labeling · Supplement 23 · standard — Letter ↗AP
2012-11-02Labeling · Supplement 19 · standard — Label ↗AP
2012-06-06Labeling · Supplement 22 · standard — Letter ↗AP
2011-01-28Labeling · Supplement 18 · standard — Letter ↗AP
2010-08-11Labeling · Supplement 17 · unknown — Label ↗AP
2009-03-06Labeling · Supplement 12 · standard — Label ↗AP
2007-10-25Labeling · Supplement 7 · standard — Label ↗AP
2004-01-15Labeling · Supplement 6 · standard — Label ↗AP
2004-01-15Efficacy · Supplement 4 · standard — Label ↗AP
2003-12-18Labeling · Supplement 5 · standard — Letter ↗AP
2002-12-17Manufacturing (CMC) · Supplement 1 · standardAP
2002-10-16Labeling · Supplement 2 · standard — Letter ↗AP
2002-05-24Type 3 - New Dosage Form · Original · standard — Label ↗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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