APPLICATION
ANDA065225
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2020-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 250MG BASE · TABLET · ORAL
Approval history
2020-04-18Labeling · Supplement 32 · standardAP
2020-04-18Labeling · Supplement 33 · standardAP
2017-09-05Labeling · Supplement 30 · standardAP
2017-09-05Labeling · Supplement 27 · standardAP
2017-09-05Labeling · Supplement 31 · standardAP
2015-03-20Labeling · Supplement 24 · standardAP
2013-06-26Labeling · Supplement 20 · standardAP
2013-02-28Labeling · Supplement 19 · standardAP
2012-12-18Labeling · Supplement 18 · standardAP
2012-02-28Labeling · Supplement 16AP
2010-07-30Labeling · Supplement 15AP
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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