Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022106
Company: SHIONOGI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DORIBAX DORIPENEM 500MG/VIAL INJECTABLE;INTRAVENOUS Discontinued None Yes No
DORIBAX DORIPENEM 250MG/VIAL INJECTABLE;INTRAVENOUS Discontinued None Yes 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
10/12/2007 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022106s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/10/2015 SUPPL-15 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/2015/022106s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022106Orig1s015ltr.pdf
04/15/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf
01/17/2014 SUPPL-12 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022106Orig1s012ltr.pdf
01/26/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022106s011lbl.pdf
04/15/2013 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf
04/15/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf
04/15/2013 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf
04/16/2009 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022106s002,022106s005ltr.pdf
02/11/2009 SUPPL-3 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s003lbl.pdf
04/16/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022106s002,022106s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2015 SUPPL-15 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/2015/022106s015lbl.pdf
01/17/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf
01/17/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf
04/15/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf
04/15/2013 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s009lbl.pdf
04/15/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s008lbl.pdf
04/15/2013 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s007lbl.pdf
01/26/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022106s011lbl.pdf
04/16/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf
04/16/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf
02/11/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s003lbl.pdf
10/12/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022106lbl.pdf

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