Application 217785

Type: NDA
Sponsor: MADRIGAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REZDIFFRA	RESMETIROM	TABLET;ORAL	60MG	Yes	No
002	REZDIFFRA	RESMETIROM	TABLET;ORAL	80MG	Yes	No
003	REZDIFFRA	RESMETIROM	TABLET;ORAL	100MG	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
N217785-001	REZDIFFRA	RESMETIROM	60MG	TABLET / ORAL	RLD	2024-03-14
N217785-002	REZDIFFRA	RESMETIROM	80MG	TABLET / ORAL	RLD	2024-03-14
N217785-003	REZDIFFRA	RESMETIROM	100MG	TABLET / ORAL	RLD, RS	2024-03-14

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217785-001	7452882	2027-09-12		Drug substance, Drug product	2024-04-03
N217785-001	10376517	2033-09-17	U-3861		2024-04-03
N217785-001	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03
N217785-001	11986481	2033-09-17	U-3861		2024-06-05
N217785-001	9266861	2033-09-17		Drug substance, Drug product	2024-04-03
N217785-001	12661359	2042-01-28	U-4568		2026-07-13
N217785-001	12667575	2045-02-04	U-4567		2026-07-13
N217785-002	7452882	2027-09-12		Drug substance, Drug product	2024-04-03
N217785-002	10376517	2033-09-17	U-3861		2024-04-03
N217785-002	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03
N217785-002	11986481	2033-09-17	U-3861		2024-06-05
N217785-002	9266861	2033-09-17		Drug substance, Drug product	2024-04-03
N217785-002	12661359	2042-01-28	U-4568		2026-07-13
N217785-002	12377104	2045-02-04	U-3861		2025-08-15
N217785-002	12667575	2045-02-04	U-4567		2026-07-13
N217785-003	7452882	2027-09-12		Drug substance, Drug product	2024-04-03
N217785-003	10376517	2033-09-17	U-3861		2024-04-03
N217785-003	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03
N217785-003	11986481	2033-09-17	U-3861		2024-06-05
N217785-003	9266861	2033-09-17		Drug substance, Drug product	2024-04-03
N217785-003	12661359	2042-01-28	U-4568		2026-07-13
N217785-003	12377104	2045-02-04	U-3861		2025-08-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217785-001	NCE	2029-03-14
N217785-002	NCE	2029-03-14
N217785-003	NCE	2029-03-14

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 · 54 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	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217785-002	REZDIFFRA	80MG	TABLET / ORAL	RLD	2024-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217785-003	REZDIFFRA	100MG	TABLET / ORAL	RLD, RS	2024-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217785-001	REZDIFFRA	60MG	TABLET / ORAL	RLD	2024-03-14	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 297 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N217785-001	7452882	2027-09-12		Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-001	10376517	2033-09-17	U-3861		2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-001	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-001	11986481	2033-09-17	U-3861		2024-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-001	9266861	2033-09-17		Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-001	12661359	2042-01-28	U-4568		2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-001	12667575	2045-02-04	U-4567		2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	7452882	2027-09-12		Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	10376517	2033-09-17	U-3861		2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	11986481	2033-09-17	U-3861		2024-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	9266861	2033-09-17		Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	12661359	2042-01-28	U-4568		2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	12377104	2045-02-04	U-3861		2025-08-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	12667575	2045-02-04	U-4567		2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	7452882	2027-09-12		Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	10376517	2033-09-17	U-3861		2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	11986481	2033-09-17	U-3861		2024-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	9266861	2033-09-17		Drug substance, Drug product	2024-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	12661359	2042-01-28	U-4568		2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	12377104	2045-02-04	U-3861		2025-08-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217785-001	7452882	2027-09-12		Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-001	10376517	2033-09-17	U-3861		2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-001	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-001	11986481	2033-09-17	U-3861		2024-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-001	9266861	2033-09-17		Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-001	12661359	2042-01-28	U-4568		2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-001	12667575	2045-02-04	U-4567		2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	7452882	2027-09-12		Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	10376517	2033-09-17	U-3861		2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	11986481	2033-09-17	U-3861		2024-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	9266861	2033-09-17		Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	12661359	2042-01-28	U-4568		2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	12377104	2045-02-04	U-3861		2025-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	12667575	2045-02-04	U-4567		2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-003	7452882	2027-09-12		Drug substance, Drug product	2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-003	10376517	2033-09-17	U-3861		2024-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-003	11564926	2033-09-17	U-3861	Drug substance, Drug product	2024-04-03	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217785-002	NCE	2029-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217785-003	NCE	2029-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217785-001	NCE	2029-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217785-002	NCE	2029-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217785-003	NCE	2029-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217785-001	NCE	2029-03-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217785-002	NCE	2029-03-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217785-003	NCE	2029-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217785-001	NCE	2029-03-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217785-002	NCE	2029-03-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217785-003	NCE	2029-03-14	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217785-001	NCE	2029-03-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217785-002	NCE	2029-03-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217785-003	NCE	2029-03-14	`a50c72e98297…`

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
REZDIFFRA	RESMETIROM	Madrigal Pharmaceuticals, Inc.	e67ea09f-a840-439c-86c8-f98585f978b2	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217785 application number: NDA217785

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84523	SUPPL	2025-12-23
84522	SUPPL	2025-12-23
84521	SUPPL	2025-12-23
84505	SUPPL	2025-12-23
84504	SUPPL	2025-12-23
84503	SUPPL	2025-12-23
78860	ORIG	2024-06-21
78488	ORIG	2024-05-17
78487	ORIG	2024-05-17