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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020572
Company: HORIZON THERAP US

Products on NDA 020572

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPHENYL	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020572

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/1996	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2022	SUPPL-25	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
10/06/2015	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/02/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/31/2009	SUPPL-16	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 020572

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2022	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf
07/29/2022	SUPPL-25	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf
03/31/2009	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf

Therapeutic Equivalents for NDA 020572

BUPHENYL

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPHENYL	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	Yes	AB	020572	HORIZON THERAP US
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	No	AB	216462	GLENMARK PHARMS LTD
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	No	AB	204395	PAR PHARM

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