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GLYCEROL PHENYLBUTYRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS INC · Approved 2026-04-15

Drug application

FDA Application #

ANDA218738

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLYCEROL PHENYLBUTYRATE

Generic name

GLYCEROL PHENYLBUTYRATE

Active ingredients

GLYCEROL PHENYLBUTYRATE

Dosage form

LIQUID

Route

ORAL

Marketing status

Prescription

Sponsor

TEVA PHARMS INC

Manufacturer

Teva Pharmaceuticals, Inc.

First approval

2026-04-15

Source

Authoritative

Drugs@FDA application overview

Machine

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