FDA.reportPublic FDA data

Application 022106

Type
NDA
Sponsor
SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORIBAXDORIPENEMINJECTABLE;INTRAVENOUS500MG/VIALYesNo
002DORIBAXDORIPENEMINJECTABLE;INTRAVENOUS250MG/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59630-309DoribaxdoripenemShionogi Inc.NDACurrent
59630-309DoribaxdoripenemShionogi Inc.NDACurrent
59630-320DoribaxdoripenemShionogi Inc.NDACurrent
59630-320DoribaxdoripenemShionogi Inc.NDACurrent
60505-6160DORIPENEMDORIPENEMApotex Corp.NDACurrent
60505-6161DORIPENEMDORIPENEMApotex Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38250SUPPL2015-08-11
29254SUPPL2015-08-11
16944SUPPL2014-01-22
6891SUPPL2014-01-21
29253SUPPL2013-04-16
29252SUPPL2013-04-16
29251SUPPL2013-04-16
6890SUPPL2013-04-16
38249SUPPL2013-04-15
38248SUPPL2013-04-15
16945SUPPL2013-04-15
16942SUPPL2013-04-15
16943SUPPL2012-01-31
38246SUPPL2009-04-23
16941SUPPL2009-04-23
29250SUPPL2009-04-21
6889SUPPL2009-04-21
38247SUPPL2009-02-12
24241ORIG2008-07-22
42415ORIG2008-03-14
6888ORIG2007-10-22
16940ORIG2007-10-15