Home Applications 217369 Application 217369
Type NDA
Sponsor BIOGEN INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZURZUVAE ZURANOLONE CAPSULE;ORAL 20MG Yes No 002 ZURZUVAE ZURANOLONE CAPSULE;ORAL 25MG Yes No 003 ZURZUVAE ZURANOLONE CAPSULE;ORAL 30MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217369-001 ZURZUVAE ZURANOLONE 20MG CAPSULE / ORAL RLD 2023-10-31 N217369-002 ZURZUVAE ZURANOLONE 25MG CAPSULE / ORAL RLD 2023-10-31 N217369-003 ZURZUVAE ZURANOLONE 30MG CAPSULE / ORAL RLD, RS 2023-10-31
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217369-001 10172871 2034-04-17 U-2552 2023-11-27 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 N217369-003 10172871 2034-04-17 U-2552 2023-11-27 N217369-003 10342810 2034-04-17 U-2552 2023-11-27 N217369-003 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 N217369-003 11236121 2037-08-23 Drug substance 2023-11-27 N217369-003 11884696 2037-08-23 U-2552 2024-02-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217369-001 NCE 2028-10-31 N217369-002 NCE 2028-10-31 N217369-003 NCE 2028-10-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 7 · 264 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217369-001 10172871 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 10172871 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 10342810 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 11236121 2037-08-23 Drug substance 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 11884696 2037-08-23 U-2552 2024-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 10172871 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 10172871 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 10342810 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 11236121 2037-08-23 Drug substance 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 11884696 2037-08-23 U-2552 2024-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217369-001 10172871 2034-04-17 U-2552 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 57 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZURZUVAE ZURANOLONE Biogen MA Inc. f18e53b0-d0bb-422d-8de7-ab64b7292b29 2026-06-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 217369 application number: NDA217369
Documents# Document, Submission type, Date table Document Submission type Date 85739 SUPPL 2026-04-24 85730 SUPPL 2026-04-21 79286 SUPPL 2024-08-02 79285 SUPPL 2024-08-02 79276 SUPPL 2024-08-02 76645 ORIG 2023-10-31 75323 ORIG 2023-08-31 75010 ORIG 2023-08-08 75012 ORIG 2023-08-07