FDA.reportPublic FDA data

Application 020193

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELMIRONPENTOSAN POLYSULFATE SODIUMCAPSULE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-098ELMIRONPENTOSAN POLYSULFATE SODIUMJanssen Pharmaceuticals, Inc.NDACurrent
50458-098ELMIRONPENTOSAN POLYSULFATE SODIUMJanssen Pharmaceuticals, Inc.NDACurrent
50458-098ELMIRONPENTOSAN POLYSULFATE SODIUMJanssen Pharmaceuticals, Inc.NDACurrent
50458-098ELMIRONPENTOSAN POLYSULFATE SODIUMJanssen Pharmaceuticals, Inc.NDACurrent
50458-098ELMIRONPENTOSAN POLYSULFATE SODIUMJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68744SUPPL2021-09-24
66783SUPPL2021-03-16
66778SUPPL2021-03-15
66777SUPPL2021-03-15
65815SUPPL2021-01-06
63602SUPPL2020-06-17
63592SUPPL2020-06-17
57641ORIG2019-02-15
41212SUPPL2012-05-09
12312SUPPL2009-01-02
2155SUPPL2008-12-23
34360SUPPL2008-07-29
24559SUPPL2008-07-29
2154SUPPL2006-09-25
34359SUPPL2006-09-21
34358SUPPL2004-08-25
24558SUPPL2004-08-25