FDA.reportPublic FDA data

Application 017031

Type
NDA
Sponsor
LABORATOIRE HRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPILLNORGESTRELTABLET;ORAL0.075MGYesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83523SUPPL 2025-09-26
83522SUPPL 2025-09-26
79438SUPPL 2024-08-20
77791SUPPL 2024-03-12
77790SUPPL 2024-03-12
74739SUPPL 2023-07-13
74733SUPPL 2023-07-13
74732SUPPL 2023-07-13
74731SUPPL 2023-07-13
49565SUPPL2017-08-29
49564SUPPL2017-08-29
49436SUPPL2017-08-16
49435SUPPL2017-08-16
531SUPPL2004-07-21