APPLICATION
ANDA065501
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-09
LATEST ACTION
2023-03-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2023-03-13Labeling · Supplement 17 · standardAP
2020-01-27Labeling · Supplement 9 · standardAP
2020-01-27Labeling · Supplement 12 · standardAP
2020-01-27Labeling · Supplement 8 · standardAP
2017-01-05Labeling · Supplement 7 · standardAP
2015-03-19Labeling · Supplement 4 · standardAP
2014-08-25Labeling · Supplement 2 · standardAP
2010-08-24Labeling · Supplement 1AP
2009-11-09OriginalAP
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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