APPLICATION
ANDA065398
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-15
LATEST ACTION
2022-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 250MG BASE · TABLET · ORAL
Approval history
2022-07-14Labeling · Supplement 25 · standardAP
2020-05-26Manufacturing (CMC) · Supplement 16AP
2020-05-01Labeling · Supplement 7 · standardAP
2020-05-01Labeling · Supplement 5 · standardAP
2020-05-01Manufacturing (CMC) · Supplement 13 · unknownAP
2020-05-01Labeling · Supplement 11 · standardAP
2017-01-27Labeling · Supplement 3 · 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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