Home Applications 215760 Application 215760
Type NDA
Sponsor ORPHALAN SA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CUVRIOR TRIENTINE TETRAHYDROCHLORIDE TABLET;ORAL 300MG No No
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 N215760-001 CUVRIOR TRIENTINE TETRAHYDROCHLORIDE 300MG TABLET / ORAL RLD, RS 2022-04-28
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 N215760-001 12662445 2039-05-03 U-4262 Drug substance, Drug product 2026-07-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215760-001 ODE-401 2029-04-28
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.
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 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 65 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 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 ea1830bbd6c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 81802-001 CUVRIOR TRIENTINE TETRAHYDROCHLORIDE Orphalan SA NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 74029 ORIG 2023-04-20 70880 ORIG 2022-05-02 70851 ORIG 2022-04-29