APPLICATION
ANDA065153
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2020-05-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AZITHROMYCINDiscontinued
AZITHROMYCIN EQ 250MG BASE · TABLET · ORAL
Approval history
2020-05-17Labeling · Supplement 23 · standardAP
2020-05-17Labeling · Supplement 21 · standardAP
2017-09-05Labeling · Supplement 18 · standardAP
2017-09-05Labeling · Supplement 20 · standardAP
2017-09-05Labeling · Supplement 19 · standardAP
2015-02-12Labeling · Supplement 16 · standardAP
2013-06-21Labeling · Supplement 15 · standardAP
2013-02-28Labeling · Supplement 13 · standardAP
2012-12-18Labeling · Supplement 12 · standardAP
2012-09-12Labeling · Supplement 11AP
2010-12-13Labeling · Supplement 8AP
2010-07-28Labeling · Supplement 6AP
2008-09-26Labeling · Supplement 5AP
2007-09-27Labeling · Supplement 3AP
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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