Home Applications 211723 Application 211723
Type NDA
Sponsor EPIZYME INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAZVERIK TAZEMETOSTAT HYDROBROMIDE TABLET;ORAL EQ 200MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N211723-001 TAZVERIK TAZEMETOSTAT HYDROBROMIDE EQ 200MG BASE TABLET / ORAL RLD 2020-01-23
Orange Book patents# Current patent rows page 1 of 1 · 46 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211723-001 10155002 2031-09-12 U-2736 2020-02-19 N211723-001 10420775 2031-09-12 U-2736 2020-02-19 N211723-001 10420775 2031-09-12 U-2852 2020-02-19 N211723-001 10420775 2031-09-12 U-2853 2020-02-19 N211723-001 11052093 2031-09-12 U-2736 Drug substance, Drug product 2021-08-03 N211723-001 11052093 2031-09-12 U-2852 Drug substance, Drug product 2021-08-03 N211723-001 11052093 2031-09-12 U-2853 Drug substance, Drug product 2021-08-03 N211723-001 12161645 2031-09-12 U-2853 2025-01-10 N211723-001 12168015 2031-09-12 Drug substance, Drug product 2025-01-10 N211723-001 12168016 2031-09-12 U-2736 2025-01-10 N211723-001 12168016 2031-09-12 U-2853 2025-01-10 N211723-001 8691507 2031-09-12 U-2852 2020-07-16 N211723-001 8765732 2031-09-12 U-2852 2020-07-16 N211723-001 8765732 2031-09-12 U-2853 2020-07-16 N211723-001 8895245 2031-09-12 U-2852 2020-07-16 N211723-001 9090562 2031-09-12 Drug substance, Drug product 2020-02-19 N211723-001 9175331 2031-09-12 U-2852 2020-07-16 N211723-001 9333217 2031-09-12 U-2852 2020-07-16 N211723-001 9334527 2031-09-12 U-2852 2020-07-16 N211723-001 9549931 2031-09-12 U-2736 2020-02-19 N211723-001 9549931 2031-09-12 U-2852 2020-02-19 N211723-001 9549931 2031-09-12 U-2853 2020-02-19 N211723-001 9855275 2031-09-12 U-2736 2020-02-19 N211723-001 9949999 2031-09-12 U-2851 2020-07-16 N211723-001 10245269 2033-04-11 U-2737 2020-02-19 N211723-001 10245269 2033-04-11 U-2851 2020-02-19 N211723-001 10245269 2033-04-11 U-2854 2020-02-19 N211723-001 10821113 2033-04-11 Drug substance, Drug product 2020-11-24 N211723-001 11491163 2033-04-11 U-2736 2022-12-08 N211723-001 11491163 2033-04-11 U-2852 2022-12-08 N211723-001 11491163 2033-04-11 U-2853 2022-12-08 N211723-001 9394283 2033-04-11 U-2852 Drug substance, Drug product 2020-02-19 N211723-001 9394283 2033-04-11 U-2853 Drug substance, Drug product 2020-02-19 N211723-001 8410088 2034-01-23 Drug substance, Drug product 2020-02-19 N211723-001 12162865 2034-06-12 U-2736 2025-01-10 N211723-001 9688665 2034-08-22 U-2736 2020-02-19 N211723-001 10369155 2035-10-16 U-2736 2020-02-19 N211723-001 10369155 2035-10-16 U-2852 2020-02-19 N211723-001 10369155 2035-10-16 U-2853 2020-02-19 N211723-001 9889138 2035-10-16 U-2736 2020-02-19 N211723-001 9889138 2035-10-16 U-2852 2020-02-19 N211723-001 9889138 2035-10-16 U-2853 2020-02-19 N211723-001 10786511 2035-12-19 Drug product 2020-10-26 N211723-001 12168014 2038-05-03 U-2736 2025-01-16 N211723-001 12168014 2038-05-03 U-2852 2025-01-16 N211723-001 12168014 2038-05-03 U-2853 2025-01-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211723-001 ODE-299 2027-01-23 N211723-001 ODE-314 2027-06-18
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 2026-08-18 06:07:40 2026-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD 2020-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD 2020-01-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 37 · 1,465 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N211723-001 10155002 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10420775 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10420775 2031-09-12 U-2852 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10420775 2031-09-12 U-2853 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11052093 2031-09-12 U-2736 Drug substance, Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11052093 2031-09-12 U-2852 Drug substance, Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11052093 2031-09-12 U-2853 Drug substance, Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12161645 2031-09-12 U-2853 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12168015 2031-09-12 Drug substance, Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12168016 2031-09-12 U-2736 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12168016 2031-09-12 U-2853 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8691507 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8765732 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8765732 2031-09-12 U-2853 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8895245 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9090562 2031-09-12 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9175331 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9333217 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9334527 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9549931 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9549931 2031-09-12 U-2853 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9549931 2031-09-12 U-2852 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9855275 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9949999 2031-09-12 U-2851 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10245269 2033-04-11 U-2737 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10245269 2033-04-11 U-2851 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10245269 2033-04-11 U-2854 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10821113 2033-04-11 Drug substance, Drug product 2020-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11491163 2033-04-11 U-2852 2022-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11491163 2033-04-11 U-2853 2022-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11491163 2033-04-11 U-2736 2022-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9394283 2033-04-11 U-2852 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9394283 2033-04-11 U-2853 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8410088 2034-01-23 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12162865 2034-06-12 U-2736 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9688665 2034-08-22 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10369155 2035-10-16 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10369155 2035-10-16 U-2853 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10369155 2035-10-16 U-2852 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9889138 2035-10-16 U-2736 2020-02-19 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 151 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72607-100 TAZVERIK tazemetostat Epizyme, Inc. NDA Current 72607-100 TAZVERIK tazemetostat Epizyme, Inc. NDA Current 72607-100 TAZVERIK tazemetostat Epizyme, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 79390 SUPPL 2024-08-14 79387 SUPPL 2024-08-14 76625 SUPPL 2023-11-17 76595 SUPPL 2023-11-17 76594 SUPPL 2023-11-17 61916 ORIG 2020-02-19 61638 ORIG 2020-01-24 61636 ORIG 2020-01-24 61635 ORIG 2020-01-24