Home Applications 020572 Application 020572
Type NDA
Sponsor HORIZON THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUPHENYL SODIUM PHENYLBUTYRATE TABLET;ORAL 500MG 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 N020572-001 BUPHENYL SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL RLD 1996-05-13
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 N020572-001 BUPHENYL 500MG TABLET / ORAL RLD 1996-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020572-001 BUPHENYL 500MG TABLET / ORAL AB RLD, RS 1996-05-13 cb3db0bc1861…
Observed Orange Book normalized TE 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BUPHENYL SODIUM PHENYLBUTYRATE Horizon Therapeutics USA, Inc. 463a36fa-3eb2-4326-8bd0-c8c7a11bca3a 2024-10-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 020572 application number: NDA020572 ndc (product): 75987-060
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 75987-060 BUPHENYL sodium phenylbutyrate Horizon Therapeutics USA, Inc. NDA Current 75987-060 BUPHENYL sodium phenylbutyrate Horizon Therapeutics USA, Inc. NDA Current 75987-060 BUPHENYL sodium phenylbutyrate Horizon Therapeutics USA, Inc. NDA Current 75987-060 BUPHENYL sodium phenylbutyrate Horizon Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71695 SUPPL 2022-08-02 71669 SUPPL 2022-08-01 25214 SUPPL 2009-04-03 12757 SUPPL 2009-04-03