Application 217369

Type
NDA
Sponsor
BIOGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZURZUVAEZURANOLONECAPSULE;ORAL20MGYesNo
002ZURZUVAEZURANOLONECAPSULE;ORAL25MGYesNo
003ZURZUVAEZURANOLONECAPSULE;ORAL30MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217369-001ZURZUVAEZURANOLONE20MGCAPSULE / ORALRLD2023-10-31
N217369-002ZURZUVAEZURANOLONE25MGCAPSULE / ORALRLD2023-10-31
N217369-003ZURZUVAEZURANOLONE30MGCAPSULE / ORALRLD, RS2023-10-31

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217369-001101728712034-04-17U-25522023-11-27
N217369-001103428102034-04-17U-25522023-11-27
N217369-00195121652034-04-17Drug substance, Drug product2023-11-27
N217369-001112361212037-08-23Drug substance2023-11-27
N217369-001118846962037-08-23U-25522024-02-26
N217369-002101728712034-04-17U-25522023-11-27
N217369-002103428102034-04-17U-25522023-11-27
N217369-00295121652034-04-17Drug substance, Drug product2023-11-27
N217369-002112361212037-08-23Drug substance2023-11-27
N217369-002118846962037-08-23U-25522024-02-26
N217369-003101728712034-04-17U-25522023-11-27
N217369-003103428102034-04-17U-25522023-11-27
N217369-00395121652034-04-17Drug substance, Drug product2023-11-27
N217369-003112361212037-08-23Drug substance2023-11-27
N217369-003118846962037-08-23U-25522024-02-26

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217369-001NCE2028-10-31
N217369-002NCE2028-10-31
N217369-003NCE2028-10-31

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.

Product history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217369-002ZURZUVAE25MGCAPSULE / ORALRLD2023-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217369-003ZURZUVAE30MGCAPSULE / ORALRLD, RS2023-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217369-001ZURZUVAE20MGCAPSULE / ORALRLD2023-10-318072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217369-001101728712034-04-17U-25522023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-001103428102034-04-17U-25522023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-00195121652034-04-17Drug substance, Drug product2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-001112361212037-08-23Drug substance2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-001118846962037-08-23U-25522024-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-002101728712034-04-17U-25522023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-002103428102034-04-17U-25522023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-00295121652034-04-17Drug substance, Drug product2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-002112361212037-08-23Drug substance2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-002118846962037-08-23U-25522024-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-003101728712034-04-17U-25522023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-003103428102034-04-17U-25522023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-00395121652034-04-17Drug substance, Drug product2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-003112361212037-08-23Drug substance2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-003118846962037-08-23U-25522024-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-001101728712034-04-17U-25522023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-001103428102034-04-17U-25522023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-00195121652034-04-17Drug substance, Drug product2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-001112361212037-08-23Drug substance2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-001118846962037-08-23U-25522024-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-002101728712034-04-17U-25522023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-002103428102034-04-17U-25522023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-00295121652034-04-17Drug substance, Drug product2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-002112361212037-08-23Drug substance2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-002118846962037-08-23U-25522024-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-003101728712034-04-17U-25522023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-003103428102034-04-17U-25522023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-00395121652034-04-17Drug substance, Drug product2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-003112361212037-08-23Drug substance2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-003118846962037-08-23U-25522024-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217369-001101728712034-04-17U-25522023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-001103428102034-04-17U-25522023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-00195121652034-04-17Drug substance, Drug product2023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-001112361212037-08-23Drug substance2023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-001118846962037-08-23U-25522024-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-002101728712034-04-17U-25522023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-002103428102034-04-17U-25522023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-00295121652034-04-17Drug substance, Drug product2023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-002112361212037-08-23Drug substance2023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-002118846962037-08-23U-25522024-02-266a471c1ec25d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N217369-001NCE2028-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-002NCE2028-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217369-003NCE2028-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-001NCE2028-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-002NCE2028-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217369-003NCE2028-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N217369-001NCE2028-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-002NCE2028-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217369-003NCE2028-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217369-001NCE2028-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217369-002NCE2028-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217369-003NCE2028-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217369-001NCE2028-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217369-002NCE2028-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217369-003NCE2028-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217369-001NCE2028-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217369-002NCE2028-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217369-003NCE2028-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217369-001NCE2028-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217369-002NCE2028-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217369-003NCE2028-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217369-001NCE2028-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217369-002NCE2028-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217369-003NCE2028-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217369-001NCE2028-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217369-002NCE2028-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217369-003NCE2028-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217369-001NCE2028-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N217369-002NCE2028-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N217369-003NCE2028-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217369-001NCE2028-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217369-002NCE2028-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217369-003NCE2028-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217369-001NCE2028-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217369-002NCE2028-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217369-003NCE2028-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217369-001NCE2028-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217369-002NCE2028-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217369-003NCE2028-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217369-001NCE2028-10-318072bd15b7f6…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZURZUVAEZURANOLONEBiogen MA Inc.f18e53b0-d0bb-422d-8de7-ab64b7292b292026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217369
application number: NDA217369

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85739SUPPL 2026-04-24
85730SUPPL 2026-04-21
79286SUPPL 2024-08-02
79285SUPPL 2024-08-02
79276SUPPL 2024-08-02
76645ORIG 2023-10-31
75323ORIG 2023-08-31
75010ORIG 2023-08-08
75012ORIG 2023-08-07