APPLICATION
ANDA065506
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-24
LATEST ACTION
2020-01-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AZITHROMYCINDiscontinued
AZITHROMYCIN EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-01-08Labeling · Supplement 17 · standardAP
2020-01-08Labeling · Supplement 15 · standardAP
2020-01-08Labeling · Supplement 18 · standardAP
2015-12-28Labeling · Supplement 12 · standardAP
2013-06-26Labeling · Supplement 9 · standardAP
2012-11-13Labeling · Supplement 6AP
2012-11-13Labeling · Supplement 7 · standardAP
2012-02-17Labeling · Supplement 4AP
2011-07-01Labeling · Supplement 2AP
2011-05-23Labeling · Supplement 1AP
2009-03-24OriginalAP
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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