Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021135
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENOFER | IRON SUCROSE | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | AB | Yes | Yes |
| VENOFER | IRON SUCROSE | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | AB | Yes | No |
| VENOFER | IRON SUCROSE | EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| VENOFER | IRON SUCROSE | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | AB | Yes | No |
| VENOFER | IRON SUCROSE | EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/06/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21135ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21135_Venofer.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/01/2024 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021135s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021135Orig1s038ltr.pdf | |
| 01/20/2021 | SUPPL-37 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021135Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021135Orig1s037ltr.pdf | |
| 09/11/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021135s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021135Orig1s036ltr.pdf | |
| 12/19/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021135s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021135Orig1s035Ltr.pdf | |
| 11/28/2017 | SUPPL-32 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021135Orig1s032ltr.pdf | |
| 05/27/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/2016 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/2012 | SUPPL-24 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021135Orig1s024ltr.pdf | |
| 03/29/2013 | SUPPL-23 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf | |
| 06/22/2011 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021135s020ltr.pdf | |
| 12/03/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021135s017ltr.pdf | |
| 02/09/2007 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf | |
| 10/17/2005 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s013ltr.pdf | |
| 03/29/2005 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s010ltr.pdf |
| 06/17/2005 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf | |
| 06/02/2003 | SUPPL-6 | Efficacy-New Dosing Regimen |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-006ltr.pdf |
| 07/26/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-005ltr.pdf | |
| 12/05/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2024 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021135s038lbl.pdf | |
| 01/20/2021 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021135Orig1s037lbl.pdf | |
| 01/20/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021135Orig1s037lbl.pdf | |
| 09/11/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021135s036lbl.pdf | |
| 12/19/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021135s035lbl.pdf | |
| 11/28/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf | |
| 11/28/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf | |
| 03/29/2013 | SUPPL-23 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf |
| 09/21/2012 | SUPPL-24 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf | |
| 06/22/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf | |
| 12/03/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf | |
| 02/09/2007 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf | |
| 02/09/2007 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf | |
| 10/17/2005 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf | |
| 06/17/2005 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf | |
| 07/26/2002 | SUPPL-5 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf |
| 11/06/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf |
VENOFER
INJECTABLE;INTRAVENOUS; EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IRON SUCROSE | IRON SUCROSE | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 208977 | INTL MEDICATION SYS |
| IRON SUCROSE | IRON SUCROSE | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 212559 | MYLAN LABS LTD |
| IRON SUCROSE | IRON SUCROSE | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 212340 | SANDOZ |
| VENOFER | IRON SUCROSE | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AB | 021135 | AM REGENT |
INJECTABLE;INTRAVENOUS; EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IRON SUCROSE | IRON SUCROSE | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 208977 | INTL MEDICATION SYS |
| IRON SUCROSE | IRON SUCROSE | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 212559 | MYLAN LABS LTD |
| IRON SUCROSE | IRON SUCROSE | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 212340 | SANDOZ |
| VENOFER | IRON SUCROSE | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AB | 021135 | AM REGENT |
INJECTABLE;INTRAVENOUS; EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IRON SUCROSE | IRON SUCROSE | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 208977 | INTL MEDICATION SYS |
| IRON SUCROSE | IRON SUCROSE | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 212559 | MYLAN LABS LTD |
| IRON SUCROSE | IRON SUCROSE | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AB | 212340 | SANDOZ |
| VENOFER | IRON SUCROSE | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AB | 021135 | AM REGENT |