Home Applications 208745 Application 208745
Type NDA
Sponsor SALIX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRULANCE PLECANATIDE TABLET;ORAL 3MG 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 N208745-001 TRULANCE PLECANATIDE 3MG TABLET / ORAL RLD, RS 2017-01-19
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 N208745-001 12146003 2034-06-05 Drug product 2024-11-25
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 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 12 · 451 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 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 12146003 2034-06-05 Drug product 2024-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 12146003 2034-06-05 Drug product 2024-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 12146003 2034-06-05 Drug product 2024-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 fd3edfee7708…
Observed Orange Book exclusivity history# 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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals Inc. NDA Current 65649-003 Trulance Plecanatide Salix Pharmaceuticals NDA Current 70194-003 Trulance Plecanatide Synergy Pharmaceuticals Inc. NDA Current 70194-003 Trulance Plecanatide Synergy Pharmaceuticals Inc. NDA Current 70194-003 Trulance Plecanatide Synergy Pharmaceuticals Inc. NDA Current