FDA.reportPublic FDA data

Application 216513

Type
NDA
Sponsor
MEDUNIK CANADA INC.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHEBURANESODIUM PHENYLBUTYRATEPELLETS;ORAL84GM/BOTYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216513-001PHEBURANESODIUM PHENYLBUTYRATE84GM/BOTPELLETS / ORALRLD, RS2022-06-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-178072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216513-001PHEBURANE84GM/BOTPELLETS / ORALRLD, RS2022-06-17a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHEBURANESODIUM PHENYLBUTYRATEMedunik USAd15f2cbf-4d22-40b5-8ef9-16b9d323a7f92026-07-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 216513
application number: NDA216513
ndc (product): 71770-200
ndc (product): 71770-210

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71770-100PHEBURANESodium phenylbutyrateMedunik USANDACurrent
71770-200PHEBURANESodium phenylbutyrateMedunik USANDACurrent
71770-200PHEBURANESodium phenylbutyrateMedunik USANDACurrent
71770-200PHEBURANESodium phenylbutyrateMedunik USANDACurrent
71770-210PHEBURANESodium phenylbutyrateMedunik USANDACurrent
71770-210PHEBURANESodium phenylbutyrateMedunik USANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73749ORIG 2023-03-14
71417ORIG2022-06-21
71385ORIG2022-06-21