Home Applications 203284 Application 203284
Type NDA
Sponsor HORIZON THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RAVICTI GLYCEROL PHENYLBUTYRATE LIQUID;ORAL 1.1GM/ML 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 N203284-001 RAVICTI GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA RLD, RS 2013-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203284-001 AA
Orange Book patents# Current patent rows page 1 of 1 · 14 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 · 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 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL AA RLD, RS 2013-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL AA RLD, RS 2013-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL AA RLD, RS 2013-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203284-001 AA 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 AA 1 31067a03dcf5…2021-12-28 21:50 UTC 2021-12 N203284-001 AA 1 782e0a99824c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N203284-001 AA 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 16 · 634 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 N203284-001 10045958 2030-09-22 U-1816 2018-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10045959 2030-09-22 U-1816 2018-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10183002 2030-09-22 U-1816 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10183003 2030-09-22 U-1816 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10183004 2030-09-22 U-1816 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10183005 2030-09-22 U-1816 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10183006 2030-09-22 U-1816 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 10668040 2030-09-22 U-1816 2020-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 8642012 2030-09-22 U-1383 2014-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 9254278 2030-09-22 U-1816 2016-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 9326966 2030-09-22 U-1816 2016-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 9561197 2030-09-22 U-1383 2017-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 9962359 2030-09-22 U-1816 2018-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 9999608 2030-09-22 U-1816 2018-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 8404215 2032-03-09 U-1383 Delist requested 2013-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10045958 2030-09-22 U-1816 2018-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10045959 2030-09-22 U-1816 2018-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183002 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183003 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183004 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183005 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183006 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10668040 2030-09-22 U-1816 2020-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 8642012 2030-09-22 U-1383 2014-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9254278 2030-09-22 U-1816 2016-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9326966 2030-09-22 U-1816 2016-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9561197 2030-09-22 U-1383 2017-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9962359 2030-09-22 U-1816 2018-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9999608 2030-09-22 U-1816 2018-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 8404215 2032-03-09 U-1383 Delist requested 2013-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203284-001 10045958 2030-09-22 U-1816 2018-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10045959 2030-09-22 U-1816 2018-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183002 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183003 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183004 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183005 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183006 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10668040 2030-09-22 U-1816 2020-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 8642012 2030-09-22 U-1383 2014-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 9254278 2030-09-22 U-1816 2016-02-29 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 75987-050 Ravicti glycerol phenylbutyrate Horizon Therapeutics, Inc. NDA Current 75987-050 Ravicti glycerol phenylbutyrate Horizon Therapeutics, Inc. NDA Current 75987-050 Ravicti glycerol phenylbutyrate Horizon Therapeutics, Inc. NDA Current 75987-050 Ravicti glycerol phenylbutyrate Horizon Therapeutics, LLC. NDA Current