FDA.reportPublic FDA data

Application 011287

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KAYEXALATESODIUM POLYSTYRENE SULFONATEPOWDER;ORAL, RECTAL453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N011287-001KAYEXALATESODIUM POLYSTYRENE SULFONATE453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / ORAL, RECTALRLD, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N011287-001KAYEXALATE453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / ORAL, RECTALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N011287-001KAYEXALATE453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / ORAL, RECTALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N011287-001KAYEXALATE453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / ORAL, RECTALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N011287-001KAYEXALATE453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / ORAL, RECTALRLD, Approved before 1982a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepackd6016e9d-dec6-4f14-b10b-7ec1aba3964a2025-10-21Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
KionexSODIUM POLYSTYRENE SULFONATEANI Pharmaceuticals, Inc.676c3d81-d575-43f6-8748-e04b7c0cafeb2025-09-19Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEATLANTIC BIOLOGICALS CORP.2d95d23e-94c8-4975-99f5-ce746dfbb60e2025-05-27Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepack9a50c6d4-e619-438d-8af9-bb758ea7ba7e2025-05-12Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEBurel Pharmaceuticals, LLC8bbeae67-a7ff-4fa6-b21e-fb8617cd91972025-05-01Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepack03a0b525-5e48-4e76-b1fa-700eab10d20a2024-04-12Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepackfe1eaaea-0697-4790-8f14-b9db08d422572024-03-15Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEKVK-Tech, Inc.905c3ee5-d1a7-4deb-a345-4a42296704fa2024-02-23Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEEpic Pharma, LLC61cc890b-eb3d-494c-ae45-629a27e721ce2023-11-29Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEChartwell RX, LLCe910a2f9-07ee-4e8f-95bd-f124e1306ff72023-10-05Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepackcae5e7d2-c6ca-485e-963e-1a147e5b11c32023-03-15Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEPuraCap Laboratories, LLC875d5288-db99-4440-8290-d9192bde6eee2022-12-28Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATESUNRISE PHARMACEUTICAL, INC.c73b9661-2378-4336-8be0-098e7c1ae5222022-08-12Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATECMP Pharma, Inc.12d48dcf-07bd-4b06-bd6c-7543f1be83572021-08-15Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATECMP Pharma, Inc.2017bfbe-cda8-46f1-b4f1-9c086c3249a92021-02-01Warnings, Adverse reactionsName fallback
generic name: SODIUM POLYSTYRENE SULFONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49186SUPPL2017-08-02
49156SUPPL2017-07-31
11928SUPPL2011-01-05
33038SUPPL2011-01-03
11927SUPPL2009-11-19
10759SUPPL2009-10-01
33037SUPPL2009-05-13
259SUPPL2009-05-04
258SUPPL2003-12-11
257SUPPL2003-06-08