Home Applications 215887 Application 215887
Type NDA
Sponsor BIOGEN MA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QALSODY TOFERSEN SOLUTION;INTRATHECAL 100MG/15ML (6.7MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N215887-001 QALSODY TOFERSEN 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 N215887-001 10968453 2035-04-01 U-3575 2023-05-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215887-001 NCE 2028-04-25 N215887-001 ODE-432 2030-04-25
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 2026-10-15 13:18:30 2026-09 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 75 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 74346 ORIG 2023-05-22 74081 ORIG 2023-04-27 74069 ORIG 2023-04-27