FDA.reportPublic FDA data

Application 022555

Type
NDA
Sponsor
PHOTOCURE ASA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYSVIEW KITHEXAMINOLEVULINATE HYDROCHLORIDEFOR SOLUTION;INTRAVESICAL100MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10511-3001CysviewHexaminolevulinate hydrochloridePhotocure ASANDACurrent
10511-3001CysviewHexaminolevulinate hydrochloridePhotocure ASANDACurrent
10511-3001CysviewHexaminolevulinate hydrochloridePhotocure ASANDACurrent
10511-3001CysviewHexaminolevulinate hydrochloridePhotocure Inc.NDACurrent
10511-3001CysviewHexaminolevulinate hydrochloridePhotocure Inc.NDACurrent
10511-3001CysviewHexaminolevulinate hydrochloridePhotocure IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52706SUPPL2018-02-23
52659SUPPL2018-02-16
17703SUPPL2016-08-02
24338ORIG2011-07-20
22054ORIG2011-07-20
29854ORIG2010-06-08
17702ORIG2010-06-03