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BUPHENYL

NDA

SODIUM PHENYLBUTYRATE | N020573 | HORIZON THERAPEUTICS US HOLDING LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs

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

SRI KRISHNA PHARMACEUTICALS LTDSODIUM PHENYLBUTYRATE USP

DMF 195692006

SRI KRISHNA PHARMACEUTICALS LTDSODIUM PHENYLBUTYRATE GRANULES 100% (KRISOSPB-100)

DMF 239722010

PH HEALTH LTDSODIUM PHENYLBUTYRATE USP

DMF 255602011

SS PHARMA LLCSODIUM PHENYLBUTYRATE USP

DMF 388902023

NAVINTA LLCSODIUM PHENYLBUTYRATE USP

DMF 409652025

NEW HORIZON PHARMA US INCSODIUM PHENYLBUTYRATE USP

DMF 424982025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 1, 2022	SUPPL -22	View Letter (PDF)
Apr 3, 2009	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3GM/TEASPOONFUL

RLD

0 patents0 exclusivities▴

POWDER;ORAL | Approved: Apr 30, 1996

No patent or exclusivity listings for this strength.