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FDA ANDA · ANDA065179
AZITHROMYCIN
azithromycin monohydrate
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA065179
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-13
LATEST ACTION
2022-05-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2022-05-31Labeling · Supplement 21 · standardAP
2019-10-24Labeling · Supplement 16 · standardAP
2019-10-24Labeling · Supplement 13 · standardAP
2013-06-27Labeling · Supplement 11 · standardAP
2012-11-14Labeling · Supplement 9 · standardAP
2012-03-01Labeling · Supplement 8AP
2011-07-01Labeling · Supplement 5AP
2005-12-13OriginalAP
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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