Home Applications 217785 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 TE codes 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 Product TE source text 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 1 of 2 · 54 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 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