Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020573
Company: HORIZON PHARMA INC
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
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
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.

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

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 PHARMA INC
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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