FDA.reportPublic FDA data

Application 021201

Type
NDA
Sponsor
CHEMISCH FBRK KRSSLR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASCLERAPOLIDOCANOLSOLUTION;INTRAVENOUS10MG/2ML (5MG/ML)YesNo
002ASCLERAPOLIDOCANOLSOLUTION;INTRAVENOUS20MG/2ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46783-121AscleraPOLIDOCANOLMerz North America, IncNDACurrent
46783-121AscleraPOLIDOCANOLMerz North America, IncNDACurrent
46783-121AscleraPOLIDOCANOLMerz North America, IncNDACurrent
46783-221AscleraPOLIDOCANOLMerz North America, IncNDACurrent
46783-221AscleraPOLIDOCANOLMerz North America, IncNDACurrent
46783-221AscleraPOLIDOCANOLMerz North America, IncNDACurrent
67850-140AscleraPOLIDOCANOLMethapharm, IncNDACurrent
67850-141AscleraPOLIDOCANOLMethapharm, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81905SUPPL 2025-04-09
81883SUPPL 2025-04-08
60211SUPPL2019-10-03
59894SUPPL2019-09-03
52789SUPPL2018-03-02
52773SUPPL2018-03-01
42017ORIG2010-04-22
24187ORIG2010-04-22
27050ORIG2010-04-09
36335ORIG2010-04-04