Home Applications 218718 Application 218718
Type NDA
Sponsor MILLICENT PR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEMLYV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET, ORALLY DISINTEGRATING;ORAL 0.02MG;1MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218718-001 FEMLYV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2024-07-22
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218718-001 12178824 2041-06-24 Drug product 2025-01-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218718-001 NP 2027-07-22
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N218718-001 FEMLYV 0.02MG;1MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2024-07-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N218718-001 12178824 2041-06-24 Drug product 2025-01-10 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N218718-001 NP 2027-07-22 a50c72e98297…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FEMLYV NORETHINDRONE ACETATE/ETHINYL ESTRADIOL Millicent US, Inc. a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 2025-09-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218718 application number: NDA218718
Documents# Document, Submission type, Date table Document Submission type Date 82998 SUPPL 2025-07-31 82986 SUPPL 2025-07-30 80273 ORIG 2024-11-22 79166 ORIG 2024-07-24 79158 ORIG 2024-07-23