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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020573
Company: HORIZON THERAP
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2022 SUPPL-22 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf
07/29/2022 SUPPL-22 Labeling-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
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