Application 020892

Type
NDA
Sponsor
ENDO PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSTAR PRESERVATIVE FREEVALRUBICINSOLUTION;INTRAVESICAL40MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67979-001ValstarvalrubicinEndo Pharmaceuticals Solutions Inc.NDACurrent
67979-001ValstarvalrubicinEndo Pharmaceuticals Solutions Inc.NDACurrent
67979-001ValstarvalrubicinEndo Pharmaceuticals Solutions Inc.NDACurrent
67979-001ValstarvalrubicinEndo Pharmaceuticals Inc.NDACurrent
67979-001ValstarvalrubicinEndo Pharmaceuticals Solutions Inc.NDACurrent
67979-001ValstarvalrubicinEndo Pharmaceuticals Inc.NDACurrent
67979-001ValstarvalrubicinEndo Pharmaceuticals Solutions Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
26125SUPPL2016-04-11
35576SUPPL2016-04-08
3659SUPPL2013-08-05
3658SUPPL2011-11-07
13674SUPPL2011-11-04
21045ORIG1998-09-25
13673ORIG1998-09-25
3657ORIG1998-09-25