APPLICATION
ANDA065419
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-24
LATEST ACTION
2020-04-15
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
AZITHROMYCINDiscontinued
AZITHROMYCIN EQ 200MG BASE/5ML · FOR SUSPENSION · ORAL
AZITHROMYCINDiscontinued
AZITHROMYCIN EQ 100MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2020-04-15Labeling · Supplement 15 · standardAP
2020-04-15Labeling · Supplement 13 · standardAP
2020-04-15Labeling · Supplement 14 · standardAP
2015-03-19Labeling · Supplement 12 · standardAP
2013-06-26Labeling · Supplement 10 · standardAP
2013-02-28Labeling · Supplement 9 · standardAP
2012-12-18Labeling · Supplement 8 · standardAP
2011-07-01Labeling · Supplement 7AP
2010-11-29Labeling · Supplement 6AP
2010-10-04Labeling · Supplement 3AP
2008-06-24OriginalAP
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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