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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203389
Company: HORIZON

Summary Review

Products on NDA 203389

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCYSBI	CYSTEAMINE BITARTRATE	EQ 25MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	Yes	No
PROCYSBI	CYSTEAMINE BITARTRATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203389

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203389s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203389Orig1s000ltr_repl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2022	SUPPL-27	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203389s027,213491s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203389Orig1s027; 213491Orig1s002ltr.pdf
06/24/2020	SUPPL-23	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203389s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203389Orig1s023ltr.pdf
05/31/2019	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203389s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203389Orig1s022ltr.pdf
12/22/2017	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203389Orig1s020ltr.pdf
11/21/2017	SUPPL-18	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/24/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203389Orig1s017ltr.pdf
03/21/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/13/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/10/2016	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/09/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/08/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/02/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/14/2015	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203389s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203389Orig1s010ltr.pdf
04/21/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/30/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/31/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/18/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/08/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203389

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2022	SUPPL-27	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203389s027,213491s002lbl.pdf
02/11/2022	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203389s027,213491s002lbl.pdf
06/24/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203389s023lbl.pdf
06/24/2020	SUPPL-23	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203389s023lbl.pdf
05/31/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203389s022lbl.pdf
12/22/2017	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s020lbl.pdf
09/24/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s017lbl.pdf
08/14/2015	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203389s010lbl.pdf
04/30/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203389s000lbl.pdf

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