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FDA ANDA · ANDA207566

AZITHROMYCIN DIHYDRATE

Sponsor: CSPC OUYI

APPLICATION
ANDA207566
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-24
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AZITHROMYCINPrescription
AZITHROMYCIN EQ 600MG BASE · TABLET · ORAL

Approval history

2021-11-22Labeling · Supplement 2 · standardAP
2020-05-01Labeling · Supplement 1 · standardAP
2018-09-24UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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