Home Applications 213535 Application 213535
Type NDA
Sponsor GENENTECH INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EVRYSDI RISDIPLAM POWDER FOR ORAL SOLUTION 1.5MG No No
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 N213535-001 EVRYSDI RISDIPLAM 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213535-001 M-270 2026-10-03 N213535-001 ODE-334 2027-08-07 N213535-001 ODE-400 2029-05-27
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 2026-02-19 14:30 UTC 2026-02 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 141 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 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 136 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current 50242-175 EVRYSDI Risdiplam Genentech Inc. NDA Current