APPLICATION
ANDA209044
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-07
LATEST ACTION
2022-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE · TABLET · ORAL
Approval history
2022-10-11Manufacturing (CMC) · Supplement 12 · unknownAP
2020-04-01Manufacturing (CMC) · Supplement 7 · unknownAP
2020-01-21Manufacturing (CMC) · Supplement 4AP
2019-02-19Manufacturing (CMC) · Supplement 1 · unknownAP
2018-12-07UNKNOWN · Original · 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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