Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205109
Company: VIFOR FRESENIUS
Company: VIFOR FRESENIUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VELPHORO | FERRIC OXYHYDROXIDE | EQ 500MG IRON | TABLET, CHEWABLE;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 |
---|---|---|---|---|---|---|---|
11/27/2013 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205109s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205109Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/27/2024 | SUPPL-10 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205109Orig1s010ltr.pdf | |
07/01/2024 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205109Orig1s009ltr.pdf | |
02/28/2020 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205109s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205109Orig1s008ltr.pdf | |
04/25/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205109Orig1s006ltr.pdf | |
08/03/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205109s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205109Orig1s005ltr.pdf | |
06/12/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/2014 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205109s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205109Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/27/2024 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s010lbl.pdf | |
08/27/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s010lbl.pdf | |
07/01/2024 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s009lbl.pdf | |
02/28/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205109s008lbl.pdf | |
04/25/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf | |
04/25/2018 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf | |
08/03/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205109s005lbl.pdf | |
09/24/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205109s001lbl.pdf | |
11/27/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205109s000lbl.pdf |