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 44.

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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212801-001	ODE-286	2027-03-06
N212801-001	ODE-535	2032-04-15
N212801-002	ODE-286	2027-03-06
N212801-002	ODE-535	2032-04-15
N212801-003	ODE-286	2027-03-06
N212801-003	ODE-535	2032-04-15

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 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N212801-001	ISTURISA	EQ 1MG BASE	TABLET / ORAL	RLD	2020-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-002	ISTURISA	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2020-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-003	ISTURISA	EQ 10MG BASE	TABLET / ORAL	RLD	2020-03-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N212801-001	ISTURISA	EQ 1MG BASE	TABLET / ORAL	RLD	2020-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-002	ISTURISA	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2020-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-003	ISTURISA	EQ 10MG BASE	TABLET / ORAL	RLD	2020-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212801-001	ISTURISA	EQ 1MG BASE	TABLET / ORAL	RLD	2020-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-002	ISTURISA	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2020-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-003	ISTURISA	EQ 10MG BASE	TABLET / ORAL	RLD	2020-03-06	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 4 of 19 · 732 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	8609862	2031-01-13	U-2770		2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	9434754	2031-01-13		Drug substance	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	10143680	2035-07-06		Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	10709691	2035-10-12	U-2770		2020-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	8609862	2031-01-13	U-2770		2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	9434754	2031-01-13		Drug substance	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	10143680	2035-07-06		Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	10709691	2035-10-12	U-2770		2020-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	8609862	2031-01-13	U-2770		2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	9434754	2031-01-13		Drug substance	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	10143680	2035-07-06		Drug product	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	10709691	2035-10-12	U-2770		2020-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	8609862	2031-01-13	U-2770		2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	9434754	2031-01-13		Drug substance	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	10143680	2035-07-06		Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	10709691	2035-10-12	U-2770		2020-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	8609862	2031-01-13	U-2770		2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	9434754	2031-01-13		Drug substance	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	10143680	2035-07-06		Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	10709691	2035-10-12	U-2770		2020-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	8609862	2031-01-13	U-2770		2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	9434754	2031-01-13		Drug substance	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	10143680	2035-07-06		Drug product	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	10709691	2035-10-12	U-2770		2020-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-001	8835646	2026-08-23		Drug substance, Drug product	2020-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-001	8314097	2029-03-27		Drug substance, Drug product	2020-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-001	8609862	2031-01-13	U-2770		2020-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-001	9434754	2031-01-13		Drug substance	2020-04-03	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 237 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N212801-001	ODE-286	2027-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-001	ODE-535	2032-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-002	ODE-286	2027-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-002	ODE-535	2032-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-003	ODE-286	2027-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212801-003	ODE-535	2032-04-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N212801-001	ODE-286	2027-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-001	ODE-535	2032-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-002	ODE-286	2027-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-002	ODE-535	2032-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-003	ODE-286	2027-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212801-003	ODE-535	2032-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212801-001	ODE-286	2027-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-001	ODE-535	2032-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-002	ODE-286	2027-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-002	ODE-535	2032-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-003	ODE-286	2027-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212801-003	ODE-535	2032-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212801-001	ODE-286	2027-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212801-002	ODE-286	2027-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212801-003	ODE-286	2027-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-001	NCE	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-001	ODE-286	2027-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-002	NCE	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-002	ODE-286	2027-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-003	NCE	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-003	ODE-286	2027-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212801-001	NCE	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-001	ODE-286	2027-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-002	NCE	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-002	ODE-286	2027-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-003	NCE	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-003	ODE-286	2027-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	NCE	2025-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	ODE-286	2027-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	NCE	2025-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	ODE-286	2027-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	NCE	2025-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	ODE-286	2027-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	NCE	2025-03-06	`b8a1b40f171c…`

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
Isturisa	OSILODROSTAT	Recordati Rare Diseases, Inc.	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212801 application number: NDA212801 ndc (product): 55292-320 ndc (product): 55292-321 ndc (product): 55292-322

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
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