APPLICATION
ANDA065211
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2020-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 250MG BASE · TABLET · ORAL
Approval history
2020-01-08Labeling · Supplement 34 · standardAP
2019-02-14Labeling · Supplement 30 · standardAP
2016-11-12Labeling · Supplement 29 · standardAP
2015-05-14Labeling · Supplement 25 · standardAP
2014-12-03Manufacturing (CMC) · Supplement 24 · unknownAP
2013-06-25Labeling · Supplement 22 · standardAP
2012-10-09Labeling · Supplement 18AP
2012-10-09Labeling · Supplement 20 · standardAP
2011-07-01Labeling · Supplement 16AP
2010-03-26Labeling · Supplement 12AP
2009-02-19Labeling · Supplement 11AP
2008-04-30Labeling · Supplement 8AP
2008-02-27Labeling · 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.
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