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GLYCEROL PHENYLBUTYRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2026-04-15

Drug application

FDA Application #

ANDA220313

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLYCEROL PHENYLBUTYRATE

Generic name

GLYCEROL PHENYLBUTYRATE

Active ingredients

GLYCEROL PHENYLBUTYRATE

Dosage form

LIQUID

Route

—

Marketing status

None (Tentative Approval)

Sponsor

AUROBINDO PHARMA

Manufacturer

Aurobindo Pharma Limited

First approval

2026-04-15

Source

Authoritative

Drugs@FDA application overview

Machine

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