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SODIUM PHENYLBUTYRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2016-06-15

Drug application

FDA Application #

ANDA203918

Application type

Abbreviated New Drug Application (Generic)

Brand name

SODIUM PHENYLBUTYRATE

Generic name

SODIUM PHENYLBUTYRATE

Active ingredients

SODIUM PHENYLBUTYRATE

Dosage form

POWDER

Route

ORAL

Marketing status

Prescription

Sponsor

PH HEALTH

Manufacturer

Par Health USA, LLC

First approval

2016-06-15

Source

Authoritative

Drugs@FDA application overview

Machine

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