APPLICATION
ANDA065400
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-15
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 600MG BASE · TABLET · ORAL
Approval history
2021-11-22Labeling · Supplement 19 · standardAP
2019-12-23Labeling · Supplement 5 · standardAP
2019-12-23Labeling · Supplement 10 · standardAP
2015-05-15OriginalAP
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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