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FDA NDA · NDA050670

ZITHROMAX

Sponsor: PFIZER

APPLICATION
NDA050670
TYPE
NDA
ORIGINAL APPROVAL
1991-11-01
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZITHROMAX · ReferenceDiscontinued
AZITHROMYCIN EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2026-07-13Labeling · Supplement 39 · standard — Label ↗AP
2021-11-22Labeling · Supplement 36 · standard — Label ↗AP
2019-04-24Labeling · Supplement 34 · standard — Letter ↗AP
2017-03-30Labeling · Supplement 32 · standard — Label ↗AP
2007-10-25Labeling · Supplement 24 · standard — Label ↗AP
2004-03-24Labeling · Supplement 21 · standard — Letter ↗AP
2004-01-15Labeling · Supplement 22 · standard — Letter ↗AP
2002-10-16Labeling · Supplement 17 · standard — Letter ↗AP
2002-07-22Labeling · Supplement 19 · standard — Letter ↗AP
2000-11-13Efficacy · Supplement 15 · unknown — Label ↗AP
2000-11-11Labeling · Supplement 14 · standardAP
1999-11-22Manufacturing (CMC) · Supplement 13 · priorityAP
1999-02-24Manufacturing (CMC) · Supplement 12 · priorityAP
1996-12-20Efficacy · Supplement 10 · standardAP
1996-11-22Efficacy · Supplement 8 · standard — Review ↗AP
1996-07-12Manufacturing (CMC) · Supplement 11 · priorityAP
1996-02-29Labeling · Supplement 3 · standardAP
1994-05-11Manufacturing (CMC) · Supplement 7 · priorityAP
1993-11-30Manufacturing (CMC) · Supplement 5 · priorityAP
1993-11-30Manufacturing (CMC) · Supplement 6 · priorityAP
1992-04-13Manufacturing (CMC) · Supplement 1 · priorityAP
1992-02-11Labeling · Supplement 2AP
1991-11-01Type 1 - New Molecular Entity · Original · priority — 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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