Home Applications 202107 Application 202107
Type NDA
Sponsor CORCEPT THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KORLYM MIFEPRISTONE TABLET;ORAL 300MG Yes Yes
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 N202107-001 KORLYM MIFEPRISTONE 300MG TABLET / ORAL AB RLD, RS 2012-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202107-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
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 · 41 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 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 17 · 656 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 N202107-001 8921348 2028-08-27 U-1643 2015-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10842801 2032-11-15 U-1643 2020-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10500216 2033-03-05 U-1643 2019-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10166242 2036-04-20 U-1643 2019-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10166243 2036-04-20 U-1643 2019-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10660904 2036-04-20 U-1643 2020-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 9943526 2036-04-20 U-1643 2018-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10006924 2036-08-12 U-1643 2018-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10495650 2036-08-12 U-1643 2019-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 9829495 2036-08-15 U-1643 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10151763 2037-01-18 U-1643 2018-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10195214 2037-06-19 U-1643 2019-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10842800 2037-06-19 U-1643 2020-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 11969435 2037-06-19 U-1643 2024-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 12097210 2037-06-19 U-1643 2024-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10231983 2038-08-22 U-1643 2019-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10314850 2038-08-22 U-1643 2019-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10780097 2038-08-22 U-1643 2020-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 8921348 2028-08-27 U-1643 2015-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10842801 2032-11-15 U-1643 2020-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10500216 2033-03-05 U-1643 2019-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10166242 2036-04-20 U-1643 2019-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10166243 2036-04-20 U-1643 2019-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10660904 2036-04-20 U-1643 2020-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 9943526 2036-04-20 U-1643 2018-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10006924 2036-08-12 U-1643 2018-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10495650 2036-08-12 U-1643 2019-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 9829495 2036-08-15 U-1643 2017-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10151763 2037-01-18 U-1643 2018-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10195214 2037-06-19 U-1643 2019-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10842800 2037-06-19 U-1643 2020-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 11969435 2037-06-19 U-1643 2024-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 12097210 2037-06-19 U-1643 2024-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10231983 2038-08-22 U-1643 2019-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10314850 2038-08-22 U-1643 2019-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10780097 2038-08-22 U-1643 2020-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202107-001 8921348 2028-08-27 U-1643 2015-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202107-001 10842801 2032-11-15 U-1643 2020-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202107-001 10500216 2033-03-05 U-1643 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202107-001 10166242 2036-04-20 U-1643 2019-01-02 6a471c1ec25d…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202107-001 ODE-22 2019-02-17 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N202107-001 ODE-22 2019-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202107-001 ODE-22 2019-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202107-001 ODE-22 2019-02-17 ea99ee380514…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current 76346-073 Korlym Mifepristone Corcept Therapeutics NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 61184 SUPPL 2019-12-06 61183 SUPPL 2019-12-06 60806 SUPPL 2019-11-12 48498 SUPPL 2017-05-23 48452 SUPPL 2017-05-19 48440 SUPPL 2017-05-18 45757 SUPPL 2016-11-01 45703 SUPPL 2016-10-28 44844 ORIG 2012-07-06 43385 ORIG 2012-07-06 9962 ORIG 2012-02-27 19061 ORIG 2012-02-22