FDA.reportPublic FDA data

Application 021258

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLIMARA PROESTRADIOL; LEVONORGESTRELFILM, EXTENDED RELEASE;TRANSDERMAL0.045MG/24HR;0.015MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-491Climara ProEstradiol and LevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-491Climara ProEstradiol and LevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-491Climara ProEstradiol and LevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-491Climara ProEstradiol and LevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-491Climara ProEstradiol and LevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-491Climara ProEstradiol and LevonorgestrelBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77559SUPPL 2024-02-20
69326SUPPL2021-11-16
69315SUPPL2021-11-16
68951SUPPL2021-10-12
50264SUPPL2017-11-02
36489SUPPL2013-10-17
4808SUPPL2013-10-11
21553ORIG2006-06-07
36488SUPPL2005-06-24
4807SUPPL2005-06-24
36487ORIG2004-04-01
4806ORIG2003-11-28