FDA.reportPublic FDA data

Application 218718

Type
NDA
Sponsor
MILLICENT PR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEMLYVETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET, ORALLY DISINTEGRATING;ORAL0.02MG;1MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218718-001FEMLYVETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218718-001121788242041-06-24Drug product2025-01-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218718-001NP2027-07-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2279d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218718-001121788242041-06-24Drug product2025-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218718-001121788242041-06-24Drug product2025-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N218718-001121788242041-06-24Drug product2025-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218718-001121788242041-06-24Drug product2025-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218718-001121788242041-06-24Drug product2025-01-10b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218718-001121788242041-06-24Drug product2025-01-10a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N218718-001NP2027-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218718-001NP2027-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N218718-001NP2027-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218718-001NP2027-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218718-001NP2027-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218718-001NP2027-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218718-001NP2027-07-222680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218718-001NP2027-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218718-001NP2027-07-22d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218718-001NP2027-07-22a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEMLYVNORETHINDRONE ACETATE/ETHINYL ESTRADIOLMillicent US, Inc.a3c99fc1-9b05-4f0a-ad00-5e3e206302c92025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218718
application number: NDA218718

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82998SUPPL 2025-07-31
82986SUPPL 2025-07-30
80273ORIG 2024-11-22
79166ORIG 2024-07-24
79158ORIG 2024-07-23