Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022180
Company: COVIS
Company: COVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FERAHEME | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 06/30/2009 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022180s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/16/2022 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022180s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022180Orig1s025ltr.pdf | |
| 09/11/2020 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022180s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022180Orig1s024ltr.pdf | |
| 10/11/2019 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022180s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022180Orig1s023ltr.pdf | |
| 11/15/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022180s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022180Orig1s016ltr.pdf | |
| 10/26/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf | |
| 07/27/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf | |
| 12/23/2013 | SUPPL-10 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf | |
| 02/02/2018 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022180s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022180Orig1s009ltr.pdf | |
| 06/05/2012 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/21/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022180s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022180s006ltr.pdf | |
| 11/24/2010 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf | |
| 11/24/2010 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/16/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022180s025lbl.pdf | |
| 09/11/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022180s024lbl.pdf | |
| 10/11/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022180s023lbl.pdf | |
| 02/02/2018 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022180s009lbl.pdf | |
| 12/22/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022180s016lbl.pdf | |
| 03/16/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf | |
| 03/16/2015 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf | |
| 12/23/2013 | SUPPL-10 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf |
| 06/21/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022180s006lbl.pdf | |
| 11/24/2010 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf | |
| 11/24/2010 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf | |
| 11/24/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf | |
| 06/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf |
FERAHEME
SOLUTION;INTRAVENOUS; EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FERAHEME | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AB | 022180 | COVIS |
| FERUMOXYTOL | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AB | 206604 | SANDOZ |