FDA.reportPublic FDA data

Application 020180

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROSCARFINASTERIDETABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0072PROSCARFINASTERIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0072PROSCARFINASTERIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0072PROSCARFINASTERIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0072PROSCARFINASTERIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0072PROSCARFINASTERIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0072PROSCARFINASTERIDEMerck Sharp & Dohme Corp.NDACurrent
78206-153PROSCARFINASTERIDEOrganon LLCNDACurrent
78206-153PROSCARFINASTERIDEOrganon LLCNDACurrent
78206-153PROSCARFINASTERIDEOrganon LLCNDACurrent
78206-153PROSCARFINASTERIDEOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85482SUPPL 2026-03-24
85420SUPPL 2026-03-20
68485SUPPL2021-08-31
68476SUPPL2021-08-27
67842SUPPL2021-06-17
67829SUPPL2021-06-16
67071SUPPL2021-04-16
67051SUPPL2021-04-14
12301SUPPL2014-03-13
2144SUPPL2014-03-13
34348SUPPL2013-01-22
2143SUPPL2013-01-22
21264SUPPL2012-04-12
21263SUPPL2012-04-12
2142SUPPL2012-04-12
34347SUPPL2012-04-11
34346SUPPL2012-04-11
12300SUPPL2012-04-11
44050ORIG2011-12-20
21262SUPPL2011-06-17
34345SUPPL2011-06-10
2141SUPPL2011-06-10
2140SUPPL2010-10-07
12299SUPPL2010-10-04
21261SUPPL2010-03-29
34344SUPPL2010-03-26
41204SUPPL2008-08-08
41205SUPPL2008-08-04
20523SUPPL2008-08-04
41209SUPPL2007-07-24
41208SUPPL2007-07-24
41206SUPPL2007-07-24
20524SUPPL2007-07-24
41207SUPPL2007-07-06
20522SUPPL2007-07-06
41202SUPPL2006-05-10
20519SUPPL2006-05-10
20525SUPPL2006-05-08
34343SUPPL2004-05-04
2139SUPPL2004-04-29
2138SUPPL2004-04-20
12298SUPPL2004-04-14
21258SUPPL2003-09-30
34342SUPPL2003-09-25
21260SUPPL2003-09-25
20517SUPPL2003-08-07
21259SUPPL2003-07-06
41203SUPPL1998-03-20
20520SUPPL1998-03-20
20521SUPPL1997-12-19
20518SUPPL1997-05-12