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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020573
Company: HORIZON THERAP US

Products on NDA 020573

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPHENYL	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020573Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2022	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020572Orig1s025,020573Orig1s022ltr.pdf
08/05/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/31/2009	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s015ltr.pdf
10/09/1998	SUPPL-2	Labeling		Label is not available on this site.
11/07/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020573

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2022	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf
07/29/2022	SUPPL-22	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf
03/31/2009	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf

Therapeutic Equivalents for NDA 020573

BUPHENYL

POWDER;ORAL; 3GM/TEASPOONFUL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPHENYL	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	Yes	AB	020573	HORIZON THERAP US
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	No	AB	203918	PAR PHARM
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	No	AB	202819	SIGMAPHARM LABS LLC

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