Home Applications 214846 Application 214846
Type NDA
Sponsor MYOVANT SCIENCES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYFEMBREE RELUGOLIX;ESTRADIOL;NORETHINDRONE ACETATE TABLET;ORAL 40MG;1MG;0.5MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N214846-001 MYFEMBREE ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 N214846-001 7300935 2029-01-28 Drug substance 2021-06-21 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 N214846-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 N214846-001 11033551 2037-09-29 U-3129 2021-06-21 N214846-001 11957684 2037-09-29 U-3129 2024-04-17 N214846-001 11793812 2038-05-03 U-2360 2023-10-25 N214846-001 12551447 2042-11-05 Drug product 2026-02-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214846-001 M-289 2026-01-27
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 2026-09-14 22:38:34 2026-08 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214846-001 MYFEMBREE 1MG;0.5MG;40MG TABLET / ORAL RLD, RS 2021-05-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 200 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 7300935 2029-01-28 Drug substance 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 11033551 2037-09-29 U-3129 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 11957684 2037-09-29 U-3129 2024-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 11793812 2038-05-03 U-2360 2023-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214846-001 12551447 2042-11-05 Drug product 2026-02-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 7300935 2029-01-28 Drug substance 2021-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 11033551 2037-09-29 U-3129 2021-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 11957684 2037-09-29 U-3129 2024-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 11793812 2038-05-03 U-2360 2023-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214846-001 12551447 2042-11-05 Drug product 2026-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214846-001 7300935 2029-01-28 Drug substance 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214846-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214846-001 11033551 2037-09-29 U-3129 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214846-001 11957684 2037-09-29 U-3129 2024-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214846-001 11793812 2038-05-03 U-2360 2023-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 7300935 2029-01-28 Drug substance 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 11033551 2037-09-29 U-3129 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 11957684 2037-09-29 U-3129 2024-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214846-001 11793812 2038-05-03 U-2360 2023-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214846-001 7300935 2026-01-28 Drug substance 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214846-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214846-001 11033551 2037-09-29 U-3129 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214846-001 11957684 2037-09-29 U-3129 2024-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214846-001 11793812 2038-05-03 U-2360 2023-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214846-001 7300935 2026-01-28 Drug substance 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214846-001 8058280 2026-01-28 Drug substance, Drug product 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214846-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 107 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 Myfembree RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE Sumitomo Pharma America, Inc fc3feb73-cc84-43a8-aa32-b262460495e8 2025-09-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214846 application number: NDA214846 ndc (product): 72974-415
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72974-415 Myfembree relugolix, estradiol hemihydrate, and norethindrone acetate Myovant Sciences, Inc. NDA Current 72974-415 Myfembree relugolix, estradiol hemihydrate, and norethindrone acetate Myovant Sciences, Inc. NDA Current 72974-415 Myfembree relugolix, estradiol hemihydrate, and norethindrone acetate Myovant Sciences, Inc. NDA Current 72974-415 Myfembree relugolix, estradiol hemihydrate, and norethindrone acetate Myovant Sciences, Inc. NDA Current 72974-415 Myfembree relugolix, estradiol hemihydrate, and norethindrone acetate Myovant Sciences, Inc. NDA Current 72974-415 Myfembree relugolix, estradiol hemihydrate, and norethindrone acetate Myovant Sciences, Inc. NDA Current