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FDA ANDA · ANDA203412

AZITHROMYCIN

azithromycin dihydrate

Sponsor: HAINAN POLY

APPLICATION
ANDA203412
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-09
LATEST ACTION
2020-04-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AZITHROMYCINPrescription
AZITHROMYCIN EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2020-04-19Labeling · Supplement 2 · standardAP
2018-10-09UNKNOWN · OriginalLetterAP
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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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