Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203389
Company: HORIZON PHARMA USA
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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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