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Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

GLYCEROL PHENYLBUTYRATE

ANDANot in Orange Book

GLYCEROL PHENYLBUTYRATE | A220579 | ESJAY PHARMA

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

NURAY CHEMICALS PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 271252013

LUPIN MANUFACTURING SOLUTIONS LTDGLYCEROL PHENYLBUTYRATE

DMF 282982014

HETERO DRUGS LTDGLYCEROL PHENYLBUTYRATE

DMF 344682020

MSN LABORATORIES PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 346182020

TAPI NL BVGLYCEROL PHENYLBUTYRATE

DMF 370422022

APITORIA PHARMA PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 403882024

NAVINTA LLCGLYCEROL PHENYLBUTYRATE

DMF 409662025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 1.1GM/ML

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LIQUID;ORAL | Approved: Jul. 28, 2026

No patent or exclusivity listings for this strength.