FDA.reportPublic FDA data

Application 205525

Type
NDA
Sponsor
BENUVIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNDROSDRONABINOLSOLUTION;ORAL5MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
20482-335SYNDROSDronabinolInsys Therapeutics, Inc.NDACurrent
20482-335SYNDROSDronabinolInsys Therapeutics, Inc.NDACurrent
78613-201SYNDROSDronabinolBenuvia Therapeutics Inc.NDACurrent
78613-201SYNDROSDronabinolBenuvia Operations, LLCNDACurrent
78613-201SYNDROSDronabinolBenuvia Therapeutics Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78518SUPPL 2024-05-20
78517SUPPL 2024-05-20
72141SUPPL2022-09-23
72140SUPPL2022-09-22
68014SUPPL2021-07-06
66837SUPPL2021-03-23
55505SUPPL2018-09-18
55495SUPPL2018-09-18
52666ORIG2018-02-16
48551SUPPL2018-01-18
48661SUPPL2017-06-06
47745ORIG2017-03-29
46985ORIG2016-07-05
46984ORIG2016-07-05