Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English