APPLICATION
ANDA065212
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2022-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE · TABLET · ORAL
Approval history
2022-05-27Labeling · Supplement 35 · standardAP
2020-01-08Labeling · Supplement 32 · standardAP
2019-02-14Labeling · Supplement 28 · standardAP
2017-01-05Manufacturing (CMC) · Supplement 25 · unknownAP
2016-11-12Labeling · Supplement 27 · standardAP
2015-05-14Labeling · Supplement 23 · standardAP
2014-12-03Manufacturing (CMC) · Supplement 22 · unknownAP
2013-06-25Labeling · Supplement 20 · standardAP
2012-10-09Labeling · Supplement 18 · standardAP
2012-10-09Labeling · Supplement 16AP
2011-07-05Labeling · Supplement 14AP
2010-03-26Labeling · Supplement 10AP
2009-02-19Labeling · Supplement 9AP
2008-04-30Labeling · Supplement 6AP
2006-05-08Labeling · Supplement 1AP
2005-11-14OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.