APPLICATION
ANDA065209
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 600MG BASE · TABLET · ORAL
Approval history
2021-11-22Labeling · Supplement 32 · standardAP
2020-01-08Labeling · Supplement 30 · standardAP
2019-02-01Labeling · Supplement 26 · standardAP
2019-02-01Labeling · Supplement 25 · standardAP
2017-01-05Manufacturing (CMC) · Supplement 23 · unknownAP
2015-05-14Labeling · Supplement 21 · standardAP
2013-06-25Labeling · Supplement 19 · standardAP
2012-10-09Labeling · Supplement 17 · standardAP
2012-03-12Labeling · Supplement 16AP
2011-07-01Labeling · Supplement 14AP
2010-08-19Labeling · Supplement 10AP
2008-06-30Labeling · Supplement 7AP
2008-01-29Labeling · Supplement 6AP
2007-06-20Labeling · Supplement 4AP
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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