APPLICATION
ANDA065302
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-11
LATEST ACTION
2024-07-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 600MG BASE · TABLET · ORAL
Approval history
2024-07-12Labeling · Supplement 12 · standardAP
2021-11-22Labeling · Supplement 11 · standardAP
2020-04-08Labeling · Supplement 6 · standardAP
2020-04-08Labeling · Supplement 10 · standardAP
2020-04-08Labeling · Supplement 5 · standardAP
2015-03-20Labeling · Supplement 3 · standardAP
2014-08-05Labeling · Supplement 2 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.