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FDA NDA · NDA050693

ZITHROMAX

Sponsor: PFIZER

APPLICATION
NDA050693
TYPE
NDA
ORIGINAL APPROVAL
1994-09-28
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

ZITHROMAX · ReferenceDiscontinued
AZITHROMYCIN EQ 1GM BASE/PACKET · FOR SUSPENSION · ORAL

Approval history

2021-11-22Labeling · Supplement 34 · standard — Label ↗AP
2019-04-24Labeling · Supplement 31 · standard — Label ↗AP
2017-03-29Labeling · Supplement 29 · standard — Label ↗AP
2017-02-10Labeling · Supplement 27 · standard — Letter ↗AP
2016-05-23Labeling · Supplement 26 · standard — Label ↗AP
2014-11-05Manufacturing (CMC) · Supplement 25 · standardAP
2014-06-06Labeling · Supplement 21 · standard — Label ↗AP
2013-02-19Labeling · Supplement 23 · standard — Label ↗AP
2012-11-02Labeling · Supplement 19 · standard — Letter ↗AP
2012-06-06Labeling · Supplement 22 · standard — Letter ↗AP
2011-01-28Labeling · Supplement 17 · standard — Label ↗AP
2010-08-11Labeling · Supplement 15 · standard — Label ↗AP
2009-03-06Labeling · Supplement 14 · standard — Label ↗AP
2007-10-25Labeling · Supplement 10 · standard — Letter ↗AP
2004-03-24Labeling · Supplement 8 · standard — Label ↗AP
2004-01-15Labeling · Supplement 9 · standard — Letter ↗AP
2002-10-16Labeling · Supplement 5 · standard — Letter ↗AP
2002-07-22Labeling · Supplement 7 · standard — Letter ↗AP
2000-11-13Efficacy · Supplement 3 · unknown — Label ↗AP
2000-11-11Labeling · Supplement 2 · standardAP
1999-11-22Manufacturing (CMC) · Supplement 1 · standardAP
1994-09-28Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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