FDA.reportPublic FDA data

Application 208224

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYLEENALEVONORGESTRELINTRAUTERINE DEVICE;INTRAUTERINE19.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-424KyleenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74182SUPPL 2023-05-05
74179SUPPL 2023-05-05
69870SUPPL2022-01-13
69834SUPPL2022-01-11
67187SUPPL2021-04-27
67080SUPPL2021-04-16
52814SUPPL2018-03-05
52794SUPPL2018-03-02
50198ORIG2017-10-26
45374ORIG2016-09-20
45373ORIG2016-09-20