FDA.reportPublic FDA data

Application 018677

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CESAMETNABILONECAPSULE;ORAL1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-1221CesametNabiloneMeda PharmaceuticalsNDACurrent
0037-1221CesametNabiloneMeda Pharmaceuticals Inc.NDACurrent
0187-1231CesametNabiloneBausch Health US LLCNDACurrent
0187-1231CesametNabiloneBausch Health US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70950SUPPL2022-05-03
70866SUPPL2022-05-02
57616ORIG2019-02-15
15086SUPPL2008-12-10
1018SUPPL2006-05-18
33553SUPPL2006-05-16