FDA.reportPublic FDA data

Application 021873

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YAZDROSPIRENONE; ETHINYL ESTRADIOLTABLET; ORAL3MG; 0.02MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YazDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.065f33e4-b587-4e66-b896-ca9ab7b7c8762025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Yaz

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21851ORIG2008-10-03
6355ORIG2006-10-13
16497ORIG2006-10-05