APPLICATION
ANDA065218
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-14
LATEST ACTION
2023-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 600MG BASE · TABLET · ORAL
Approval history
2023-02-06Labeling · Supplement 26 · standardAP
2021-11-22Labeling · Supplement 24 · standardAP
2020-01-08Labeling · Supplement 21 · standardAP
2020-01-08Labeling · Supplement 22 · standardAP
2020-01-08Labeling · Supplement 20 · standardAP
2020-01-08Labeling · Supplement 19 · standardAP
2016-11-08Labeling · Supplement 15 · standardAP
2010-07-30Labeling · Supplement 13AP
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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