Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021337
Company: MERCK SHARP DOHME
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
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
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 AUROBINDO 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 MERCK SHARP DOHME

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