Home Applications 208711 Application 208711
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EGATEN TRICLABENDAZOLE TABLET;ORAL 250MG Yes Yes
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 N208711-001 EGATEN TRICLABENDAZOLE 250MG TABLET / ORAL RLD, RS 2019-02-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208711-001 ODE-228 2026-02-13
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 cb3db0bc1861…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 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 EGATEN TRICLABENDAZOLE Novartis Pharmaceuticals Corporation 5552884e-10ea-450c-9658-d3d4f33c946e 2026-06-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 208711 application number: NDA208711 ndc (product): 0078-0937
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 0078-0937 EGATEN triclabendazole Novartis Pharmaceuticals Corporation NDA Current 0078-0937 EGATEN triclabendazole Novartis Pharmaceuticals Corporation NDA Current 0078-0937 EGATEN triclabendazole Novartis Pharmaceuticals Corporation NDA Current 0078-0937 EGATEN triclabendazole Novartis Pharmaceuticals Corporation NDA Current 0078-0937 EGATEN triclabendazole Novartis Pharmaceuticals Corporation NDA Current 0078-0937 EGATEN triclabendazole Novartis Pharmaceuticals Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70203 SUPPL 2022-02-22 70188 SUPPL 2022-02-18 57949 ORIG 2019-03-11 57586 ORIG 2019-02-27 57604 ORIG 2019-02-14