Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021632
Company: VICURON HOLDINGS
Company: VICURON HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERAXIS | ANIDULAFUNGIN | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
| ERAXIS | ANIDULAFUNGIN | 100MG/VIAL | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 02/17/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021948s000,021632s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021632_021948_EraxisTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/05/2020 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021632Orig1s030ltr.pdf | |
| 09/22/2020 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021632Orig1s027, s029ltr.pdf | |
| 09/22/2020 | SUPPL-27 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021632Orig1s027, s029ltr.pdf | |
| 01/05/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021632s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021632Orig1s026ltr.pdf | |
| 08/17/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021632s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021632Orig1s024ltr.pdf |
| 12/02/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/2010 | SUPPL-13 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021632s013ltr.pdf |
| 07/20/2012 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021632s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021632Orig1s011ltr.pdf | |
| 06/05/2009 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021632s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021632s010ltr.pdf | |
| 11/09/2007 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s006ltr.pdf | |
| 02/02/2007 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s004.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s004ltr.pdf | |
| 11/15/2006 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s003ltr.pdf | |
| 08/07/2006 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s002LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/05/2020 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632s030lbl.pdf | |
| 09/22/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf | |
| 09/22/2020 | SUPPL-27 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf | |
| 01/05/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021632s026lbl.pdf | |
| 08/17/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021632s024lbl.pdf |
| 07/20/2012 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021632s011lbl.pdf | |
| 06/05/2009 | SUPPL-10 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021632s010lbl.pdf | |
| 11/09/2007 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s006lbl.pdf | |
| 02/02/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s004.pdf | |
| 11/15/2006 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf | |
| 11/15/2006 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf | |
| 08/07/2006 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf | |
| 08/07/2006 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf | |
| 02/17/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf |