APPLICATION
ANDA065500
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-26
LATEST ACTION
2020-01-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-01-27Labeling · Supplement 7 · standardAP
2020-01-27Labeling · Supplement 13 · standardAP
2020-01-27Labeling · Supplement 8 · standardAP
2015-03-19Labeling · Supplement 5 · standardAP
2015-03-19Labeling · Supplement 3 · standardAP
2012-10-11Labeling · Supplement 2 · standardAP
2009-06-26OriginalAP
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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