FDA.reportPublic FDA data

Application 021885

Type
NDA
Sponsor
BERLEX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLIMARA PROESTRADIOL; LEVONORGESTRELSYSTEM; TRANSDERMAL0.045MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 ยท 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 reactionsName fallback
brand name: Climara Pro

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42338ORIG2007-07-02
6388ORIG2006-01-06
37830ORIG2006-01-05