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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203284
Company: HORIZON THERAP US

Medication Guide

Products on NDA 203284

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAVICTI	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203284

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2021	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203284Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203284Orig1s012ltr.pdf
10/04/2019	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203284s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203284Orig1s011ltr.pdf
12/21/2018	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203284s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203284Orig1s010Ltr.pdf
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

Labels for NDA 203284

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203284Orig1s012lbl.pdf
09/03/2021	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203284Orig1s012lbl.pdf
10/04/2019	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203284s011lbl.pdf
12/21/2018	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203284s010lbl.pdf
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

Therapeutic Equivalents for NDA 203284

RAVICTI

LIQUID;ORAL; 1.1GM/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	220313	AUROBINDO PHARMA
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	207694	LUPIN
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	219540	MSN
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	220568	NAVINTA LLC
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	205742	PH HEALTH
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	218738	TEVA PHARMS INC
RAVICTI	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	Yes	AA	203284	HORIZON THERAP US

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