Home Applications 214429 Application 214429
Type NDA
Sponsor DRUGS FOR NEGLECTED DISEASES INITIATIVE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEXINIDAZOLE FEXINIDAZOLE TABLET;ORAL 600MG 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 N214429-001 FEXINIDAZOLE FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214429-001 NCE 2026-07-16 N214429-001 ODE-359 2028-07-16
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 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 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 0024-4512 Fexinidazole Fexinidazole Sanofi-Aventis U.S. LLC NDA Current 0024-4512 Fexinidazole Fexinidazole Sanofi-Aventis U.S. LLC NDA Current 0024-4512 Fexinidazole Fexinidazole Sanofi-Aventis U.S. LLC NDA Current 0024-4512 Fexinidazole Fexinidazole Sanofi-Aventis U.S. LLC NDA Current 0024-4512 Fexinidazole Fexinidazole Sanofi-Aventis U.S. LLC NDA Current 0024-4512 Fexinidazole Fexinidazole Sanofi-Aventis U.S. LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 79719 SUPPL 2024-09-24 79718 SUPPL 2024-09-24 79702 SUPPL 2024-09-23 79701 SUPPL 2024-09-23 69706 SUPPL 2021-12-21 69616 SUPPL 2021-12-17 68341 ORIG 2021-08-11 68136 ORIG 2021-07-20 68113 ORIG 2021-07-19