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AZITHROMYCIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZHEJIANG POLY PHARM · Approved 2023-07-27

Drug application

FDA Application #

ANDA217036

Application type

Abbreviated New Drug Application (Generic)

Brand name

AZITHROMYCIN

Generic name

AZITHROMYCIN DIHYDRATE

Active ingredients

AZITHROMYCIN

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ZHEJIANG POLY PHARM

Manufacturer

Slate Run Pharmaceuticals, LLC

First approval

2023-07-27

Source

Authoritative

Drugs@FDA application overview

Machine

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