APPLICATION
ANDA211147
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-31
LATEST ACTION
2023-03-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 100MG BASE/5ML · FOR SUSPENSION · ORAL
AZITHROMYCINPrescription
AZITHROMYCIN EQ 200MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2023-03-17Labeling · Supplement 6 · standardAP
2020-01-13Labeling · Supplement 3 · standardAP
2018-07-31UNKNOWN · 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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