APPLICATION
ANDA203294
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-19
LATEST ACTION
2023-08-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2023-08-02Labeling · Supplement 12 · standardAP
2023-08-02Labeling · Supplement 9 · standardAP
2020-01-27Labeling · Supplement 3 · standardAP
2020-01-27Labeling · Supplement 6 · standardAP
2020-01-27Labeling · Supplement 2 · standardAP
2016-12-30Labeling · Supplement 1 · standardAP
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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