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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021258-001CLIMARA PROESTRADIOL; LEVONORGESTREL0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021258-001CLIMARA PRO0.045MG/24HR;0.015MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2003-11-21a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021258
application number: NDA021258
ndc (product): 50419-491

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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