FDA.reportPublic FDA data

Application 020718

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INTEGRILINEPTIFIBATIDEINJECTABLE;INJECTION2MG/MLYesYes
002INTEGRILINEPTIFIBATIDEINJECTABLE;INJECTION75MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1136IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent
0085-1177IntegrilinEptifibatideMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66440SUPPL2021-03-02
66418SUPPL2021-03-01
3201SUPPL2013-03-26
35225SUPPL2013-03-25
3200SUPPL2011-04-04
35224SUPPL2011-04-01
35223SUPPL2009-01-02
25629SUPPL2008-12-19
35222SUPPL2005-10-14
3199SUPPL2005-10-14
3198SUPPL2004-07-21
35221SUPPL2003-06-22
3197SUPPL2003-06-22
35220SUPPL2001-06-08
35219SUPPL2001-06-08
25628SUPPL2001-06-08
20878SUPPL2001-06-08
20877SUPPL2001-06-08
3196SUPPL2001-06-08
41613SUPPL1999-09-20
35218SUPPL1999-09-20
25627SUPPL1999-09-20
35217ORIG1998-05-18
20876ORIG1998-05-18
3195ORIG1998-05-18