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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022106
Company: SHIONOGI INC

Summary Review

Products on NDA 022106

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DORIBAX	DORIPENEM	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
DORIBAX	DORIPENEM	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022106

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

Labels for NDA 022106

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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