APPLICATION
ANDA065405
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-11
LATEST ACTION
2024-07-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE · TABLET · ORAL
Approval history
2024-07-12Labeling · Supplement 14 · standardAP
2020-04-07Labeling · Supplement 12 · standardAP
2020-04-07Labeling · Supplement 8 · standardAP
2020-04-07Labeling · Supplement 7 · standardAP
2015-02-12Labeling · Supplement 5 · standardAP
2014-08-05Labeling · Supplement 4 · standardAP
2009-11-03Manufacturing (CMC) · Supplement 1AP
2008-02-11OriginalAP
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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