Home Applications 213931 Application 213931
Type NDA
Sponsor ARDELYX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XPHOZAH TENAPANOR HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Yes No 002 XPHOZAH TENAPANOR HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Yes No 003 XPHOZAH TENAPANOR HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N213931-001 XPHOZAH TENAPANOR HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 N213931-002 XPHOZAH TENAPANOR HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 N213931-003 XPHOZAH TENAPANOR HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213931-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N213931-001 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 N213931-001 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 N213931-001 10272079 2034-04-10 U-3736 2023-11-14 N213931-001 10272079 2034-04-10 U-381 2023-11-14 N213931-001 10940146 2034-04-10 U-3736 2023-11-14 N213931-001 10940146 2034-04-10 U-381 2023-11-14 N213931-001 12539299 2042-11-26 Drug product 2026-02-11 N213931-002 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N213931-002 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 N213931-002 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 N213931-002 10272079 2034-04-10 U-3736 2023-11-14 N213931-002 10272079 2034-04-10 U-381 2023-11-14 N213931-002 10940146 2034-04-10 U-3736 2023-11-14 N213931-002 10940146 2034-04-10 U-381 2023-11-14 N213931-002 12539299 2042-11-26 Drug product 2026-02-11 N213931-003 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N213931-003 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 N213931-003 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 N213931-003 10272079 2034-04-10 U-3736 2023-11-14 N213931-003 10272079 2034-04-10 U-381 2023-11-14 N213931-003 10940146 2034-04-10 U-3736 2023-11-14 N213931-003 10940146 2034-04-10 U-381 2023-11-14 N213931-003 12539299 2042-11-26 Drug product 2026-02-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213931-001 NP 2026-10-17 N213931-002 NP 2026-10-17 N213931-003 NP 2026-10-17
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 · 57 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 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 10 · 366 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 N213931-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10272079 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10272079 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10940146 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10940146 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10272079 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10272079 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10940146 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10940146 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10272079 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10272079 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10940146 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10940146 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10272079 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10272079 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10940146 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10940146 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10272079 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10272079 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10940146 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10940146 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-003 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-003 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 90 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.
Documents# Document, Submission type, Date table Document Submission type Date 82591 SUPPL 2025-06-17 82587 SUPPL 2025-06-17 81715 SUPPL 2025-03-25 81704 SUPPL 2025-03-24 79581 ORIG 2024-09-12 75856 ORIG 2023-10-19 75837 ORIG 2023-10-18