APPLICATION
ANDA065246
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-06
LATEST ACTION
2023-05-28
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
2023-05-28Labeling · Supplement 30 · standardAP
2020-01-13Labeling · Supplement 26 · standardAP
2020-01-13Labeling · Supplement 25 · standardAP
2017-06-28Labeling · Supplement 24 · standardAP
2017-06-28Labeling · Supplement 22 · standardAP
2017-06-28Labeling · Supplement 19 · standardAP
2017-06-28Labeling · Supplement 23 · standardAP
2013-07-11Labeling · Supplement 16 · standardAP
2013-02-28Labeling · Supplement 15 · standardAP
2012-12-18Labeling · Supplement 14 · standardAP
2012-02-28Labeling · Supplement 11AP
2009-10-22Labeling · Supplement 5AP
2009-09-28Labeling · Supplement 7AP
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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