Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203284
Company: HORIZON THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAVICTI GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID;ORAL Prescription None 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
02/01/2013 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203284s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203284Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203284Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2017 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203284Orig1s005ltr.pdf
09/08/2016 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203284s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203284Orig1s004ltr.pdf
07/27/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/24/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203284s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203284Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2017 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf
09/08/2016 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203284s004lbl.pdf
06/24/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203284s001lbl.pdf
02/01/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203284s000lbl.pdf

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