Drugs@FDA: FDA-Approved Drugs
Company: HORIZON
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 |
---|---|---|---|---|---|
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-Patient Package Insert, Labeling-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 |
---|---|---|---|---|---|
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 |