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FDA ANDA · ANDA207398

AZITHROMYCIN

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA207398
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-05
LATEST ACTION
2022-01-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE · TABLET · ORAL

Approval history

2022-01-12Labeling · Supplement 9 · standardAP
2020-05-14Labeling · Supplement 4 · standardAP
2018-07-05UNKNOWN · Original · standardAP
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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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