FDA.reportPublic FDA data

Application 210942

Type
NDA
Sponsor
AVION PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLOPERBACOLCHICINESOLUTION;ORAL0.6MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72690-010GloperbacolchicineROMEG Therapeutics, LLCNDACurrent
75854-801GloperbacolchicineAvion Pharmaceuticals, LLCNDACurrent
75854-801GloperbacolchicineAvion Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79512SUPPL 2024-09-02
79013SUPPL 2024-09-02
79504SUPPL 2024-08-29
79503SUPPL 2024-08-29
67712SUPPL2021-06-04
67711SUPPL2021-06-04
67699SUPPL2021-06-04
58132ORIG2019-03-28
57550ORIG2019-02-13
57392ORIG2019-01-31
57391ORIG2019-01-31