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ONDANSETRON HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 2007-06-25

Drug application

FDA Application #

ANDA078127

Application type

Abbreviated New Drug Application (Generic)

Brand name

ONDANSETRON HYDROCHLORIDE

Generic name

ONDANSETRON

Active ingredients

ONDANSETRON HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

PHARM ASSOC

Manufacturer

PAI Holdings, LLC dba PAI Pharma

First approval

2007-06-25

Source

Authoritative

Drugs@FDA application overview

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