Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021337
Company: MSD SUB MERCK
Company: MSD SUB MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVANZ | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2001 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21337lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21337ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21337_Invanz.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/17/2022 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021337s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021337Orig1s051ltr.pdf | |
| 12/22/2020 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021337Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021337Orig1s049ltr.pdf | |
| 09/20/2019 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021337s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021337Orig1s048ltr.pdf | |
| 12/19/2018 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021337s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021337Orig1s047Ltr.pdf | |
| 09/12/2018 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021337s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021337Orig1s046ltr.pdf | |
| 09/08/2017 | SUPPL-45 | Labeling-Container/Carton Labels |
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/2017/021337Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021337Orig1s045ltr.pdf |
| 03/16/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2014 | SUPPL-42 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021337s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021337Orig1s042ltr.pdf | |
| 07/24/2013 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021337s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021337Orig1s041ltr.pdf | |
| 08/05/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2013 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/2012 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021337s038ltr.pdf | |
| 02/17/2012 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s037lbl.pdf | |
| 05/25/2010 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021337s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021337s034ltr.pdf | |
| 10/06/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021337s033ltr.pdf | |
| 07/22/2011 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021337s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021337s031ltr.pdf | |
| 12/13/2009 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021337s030ltr.pdf | |
| 03/25/2008 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021337s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021337s028ltr.pdf | |
| 11/16/2007 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021337s026ltr.pdf |
| 12/28/2006 | SUPPL-25 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/10/2006 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021337s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021337s021LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021337Orig1s021.pdf | |
| 10/14/2005 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021337s019ltr.pdf | |
| 05/18/2005 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021337s018ltr.pdf | |
| 01/24/2005 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21337s017ltr.pdf |
| 09/10/2004 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337s015ltr.pdf |
| 05/20/2004 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337slr014ltr.pdf |
| 04/30/2004 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337slr013ltr.pdf |
| 12/20/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/17/2022 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021337s051lbl.pdf | |
| 12/22/2020 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021337Orig1s049lbl.pdf | |
| 09/20/2019 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021337s048lbl.pdf | |
| 12/19/2018 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021337s047lbl.pdf | |
| 09/12/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021337s046lbl.pdf | |
| 09/08/2017 | SUPPL-45 | Labeling-Container/Carton Labels | 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/2017/021337Orig1s045lbl.pdf |
| 09/30/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021337s042lbl.pdf | |
| 09/30/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021337s042lbl.pdf | |
| 07/24/2013 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021337s041lbl.pdf | |
| 03/02/2012 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s038lbl.pdf | |
| 02/17/2012 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s037lbl.pdf | |
| 07/22/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021337s031lbl.pdf | |
| 05/25/2010 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021337s034lbl.pdf | |
| 12/13/2009 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s030lbl.pdf | |
| 10/06/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s033lbl.pdf | |
| 03/25/2008 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021337s028lbl.pdf | |
| 08/10/2006 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021337s021lbl.pdf | |
| 10/14/2005 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s019lbl.pdf | |
| 05/18/2005 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf | |
| 11/21/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21337lbl.pdf |
INVANZ
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 208790 | ACS DOBFAR SPA |
| ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 209133 | EUGIA PHARMA |
| ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 212040 | GLAND PHARMA LTD |
| ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 207647 | SAVIOR LIFETEC CORP |
| INVANZ | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AP | 021337 | MSD SUB MERCK |