Application 218201

Type
NDA
Sponsor
SEBELA WOMENS HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIUDELLACOPPERSYSTEM;INTRAUTERINEN/AYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83637SUPPL 2025-10-03
83636SUPPL 2025-10-03
83635SUPPL 2025-10-03
81368ORIG 2025-02-25
81343ORIG 2025-02-25