Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020572
Company: HORIZON THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPHENYL SODIUM PHENYLBUTYRATE 500MG TABLET;ORAL Prescription AB Yes Yes
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
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.

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

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
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 500MG TABLET;ORAL Prescription No AB 090910 ALVOGEN
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 500MG TABLET;ORAL Prescription No AB 204395 PAR PHARM

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