Home Applications 212801 Application 212801
Type NDA
Sponsor RECORDATI RARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISTURISA OSILODROSTAT PHOSPHATE TABLET;ORAL EQ 1MG BASE Yes No 002 ISTURISA OSILODROSTAT PHOSPHATE TABLET;ORAL EQ 5MG BASE Yes No 003 ISTURISA OSILODROSTAT PHOSPHATE TABLET;ORAL EQ 10MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212801-001 ISTURISA OSILODROSTAT PHOSPHATE EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 N212801-002 ISTURISA OSILODROSTAT PHOSPHATE EQ 5MG BASE TABLET / ORAL RLD, RS 2020-03-06 N212801-003 ISTURISA OSILODROSTAT PHOSPHATE EQ 10MG BASE TABLET / ORAL RLD 2020-03-06
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212801-001 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 N212801-001 8609862 2031-01-13 U-4529 2020-04-03 N212801-001 9434754 2031-01-13 Drug substance 2020-04-03 N212801-001 8314097 2033-05-20 Drug substance, Drug product 2020-04-03 N212801-001 10143680 2035-07-06 Drug product 2020-04-03 N212801-001 10709691 2035-10-12 U-4529 2020-08-06 N212801-002 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 N212801-002 8609862 2031-01-13 U-4529 2020-04-03 N212801-002 9434754 2031-01-13 Drug substance 2020-04-03 N212801-002 8314097 2033-05-20 Drug substance, Drug product 2020-04-03 N212801-002 10143680 2035-07-06 Drug product 2020-04-03 N212801-002 10709691 2035-10-12 U-4529 2020-08-06 N212801-003 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 N212801-003 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 N212801-003 8609862 2031-01-13 U-2770 2020-04-03 N212801-003 9434754 2031-01-13 Drug substance 2020-04-03 N212801-003 10143680 2035-07-06 Drug product 2020-04-03 N212801-003 10709691 2035-10-12 U-2770 2020-08-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 3 · 111 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 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 17 · 678 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 N212801-001 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 8609862 2031-01-13 U-4177 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 8609862 2031-01-13 U-2770 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 9434754 2031-01-13 Drug substance 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 10143680 2035-07-06 Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 10709691 2035-10-12 U-4177 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 10709691 2035-10-12 U-2770 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8609862 2031-01-13 U-4177 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8609862 2031-01-13 U-2770 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 9434754 2031-01-13 Drug substance 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 10143680 2035-07-06 Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 10709691 2035-10-12 U-4177 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 10709691 2035-10-12 U-2770 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 8609862 2031-01-13 U-2770 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 9434754 2031-01-13 Drug substance 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 10143680 2035-07-06 Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 10709691 2035-10-12 U-2770 2020-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8609862 2031-01-13 U-4177 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8609862 2031-01-13 U-2770 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 9434754 2031-01-13 Drug substance 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 10143680 2035-07-06 Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 10709691 2035-10-12 U-4177 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 10709691 2035-10-12 U-2770 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8609862 2031-01-13 U-4177 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8609862 2031-01-13 U-2770 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 9434754 2031-01-13 Drug substance 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 10143680 2035-07-06 Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 10709691 2035-10-12 U-4177 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 10709691 2035-10-12 U-2770 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-003 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-003 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 219 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55292-320 Isturisa Osilodrostat Recordati Rare Diseases, Inc. NDA Current 55292-320 Isturisa Osilodrostat Recordati Rare Diseases, Inc. NDA Current 55292-321 Isturisa Osilodrostat Recordati Rare Diseases, Inc. NDA Current 55292-321 Isturisa Osilodrostat Recordati Rare Diseases, Inc. NDA Current 55292-322 Isturisa Osilodrostat Recordati Rare Diseases, Inc. NDA Current 55292-322 Isturisa Osilodrostat Recordati Rare Diseases, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84073 SUPPL 2025-11-05 84072 SUPPL 2025-11-05 82752 SUPPL 2025-07-08 82743 SUPPL 2025-07-08 82004 SUPPL 2025-04-25 81934 SUPPL 2025-04-21 62442 ORIG 2020-04-06 62102 ORIG 2020-03-10 62085 ORIG 2020-03-09