FDA.reportPublic FDA data

Application 021225

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRENALEVONORGESTRELINTRAUTERINE DEVICE;INTRAUTERINE52MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-423MirenaLevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71805SUPPL2022-08-15
71797SUPPL2022-08-15
68354SUPPL2021-08-12
68351SUPPL2021-08-12
67758SUPPL2021-06-10
67747SUPPL2021-06-09
67609SUPPL2021-05-27
64356SUPPL2020-08-21
64348SUPPL2020-08-21
48688SUPPL2017-06-09
48684SUPPL2017-06-08
48560SUPPL2017-05-30
48556SUPPL2017-05-30
46524SUPPL2016-12-23
46506SUPPL2016-12-21
21520SUPPL2016-02-03
36388SUPPL2015-10-26
4681SUPPL2015-10-26
42036SUPPL2015-03-09
36390SUPPL2014-05-30
36389SUPPL2013-08-09
4682SUPPL2013-08-08
4680SUPPL2009-11-10
36387SUPPL2009-10-14
4679SUPPL2008-07-24
36386SUPPL2008-07-22
4678SUPPL2008-06-06
4677SUPPL2008-05-30
21519ORIG2004-05-06
27113SUPPL2004-01-14
27114SUPPL2003-08-29
53316ORIG1900-01-01
53315ORIG1900-01-01
53314ORIG1900-01-01