APPLICATION
ANDA065223
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2020-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE · TABLET · ORAL
Approval history
2020-04-18Labeling · Supplement 30 · standardAP
2020-04-18Labeling · Supplement 29 · standardAP
2017-09-05Labeling · Supplement 24 · standardAP
2017-09-05Labeling · Supplement 27 · standardAP
2017-09-05Labeling · Supplement 28 · standardAP
2015-03-20Labeling · Supplement 20 · standardAP
2013-06-26Labeling · Supplement 17 · standardAP
2010-07-28Labeling · 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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