FDA.reportPublic FDA data

Application 050587

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMAXINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 250MG BASE/VIAL;250MG/VIALYesNo
002PRIMAXINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 500MG BASE/VIAL;500MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3516PRIMAXINimipenem and cilastatin sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3516PRIMAXINimipenem and cilastatin sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3516PRIMAXINimipenem and cilastatin sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3516PRIMAXINimipenem and cilastatin sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3516PRIMAXINimipenem and cilastatin sodiumMerck Sharp & Dohme LLCNDACurrent
0006-3516PRIMAXINimipenem and cilastatin sodiumMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70052SUPPL2022-02-02
69999SUPPL2022-01-31
57691ORIG2019-02-15
56883SUPPL2018-12-21
56740SUPPL2018-12-14
46448SUPPL2016-12-21
46270SUPPL2016-12-20
17905SUPPL2014-12-17
7855SUPPL2014-12-17
7854SUPPL2012-04-18
39013SUPPL2012-04-16
30126SUPPL2009-11-20
39012SUPPL2009-09-22
7853SUPPL2008-12-19
42652SUPPL2008-08-11
22164SUPPL2008-08-01
30125SUPPL2008-04-02
39011SUPPL2008-04-01
42658SUPPL2008-02-19
42657SUPPL2008-02-19
42653SUPPL2008-02-19
42651SUPPL2008-02-19
22163SUPPL2008-02-19
42656SUPPL2007-11-19
42655SUPPL2007-11-19
42654SUPPL2007-11-19
30124SUPPL2006-08-07
7852SUPPL2004-05-26
30123SUPPL2003-03-10
7851SUPPL2001-11-30
39010SUPPL1998-04-08
7850SUPPL1998-04-08