Home Applications 216403 Application 216403
Type NDA
Sponsor TRAVERE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FILSPARI SPARSENTAN TABLET;ORAL 200MG Yes No 002 FILSPARI SPARSENTAN TABLET;ORAL 400MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216403-001 FILSPARI SPARSENTAN 200MG TABLET / ORAL RLD 2023-02-17 N216403-002 FILSPARI SPARSENTAN 400MG TABLET / ORAL RLD, RS 2023-02-17
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216403-001 9662312 2030-03-29 U-4495 2026-05-07 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 N216403-001 9993461 2030-03-29 U-4495 2023-03-14 N216403-002 9662312 2030-03-29 U-4495 2026-05-07 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 N216403-002 9993461 2030-03-29 U-4495 2023-03-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
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 · 50 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 2026-09-14 22:38:34 2026-08 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 a72a2bbeb626…
Observed Orange Book patent history# Patent history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216403-001 9662312 2030-03-29 U-4495 2026-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-001 9993461 2030-03-29 U-4495 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9662312 2030-03-29 U-4495 2026-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9993461 2030-03-29 U-4495 2023-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216403-001 9662312 2030-03-29 U-4495 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-001 9993461 2030-03-29 U-4495 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9662312 2030-03-29 U-4495 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9993461 2030-03-29 U-4495 2023-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 130 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 FILSPARI SPARSENTAN Travere Therapeutics, Inc. d7354af1-f304-f4d9-e053-2995a90ab219 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216403 application number: NDA216403
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.