FDA.reportPublic FDA data

Application 089049

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATESUSPENSION;ORAL, RECTAL15GM/60MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089049-001SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A089049-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A089049-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089049-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089049-001AA1ea99ee380514…

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
brand name: SODIUM POLYSTYRENE SULFONATE
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
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepack9a50c6d4-e619-438d-8af9-bb758ea7ba7e2025-05-12Warnings, Adverse reactionsName fallback
brand name: SODIUM POLYSTYRENE SULFONATE
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEBurel Pharmaceuticals, LLC8bbeae67-a7ff-4fa6-b21e-fb8617cd91972025-05-01Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepack03a0b525-5e48-4e76-b1fa-700eab10d20a2024-04-12Warnings, Adverse reactionsName fallback
brand name: SODIUM POLYSTYRENE SULFONATE
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepackfe1eaaea-0697-4790-8f14-b9db08d422572024-03-15Warnings, Adverse reactionsName fallback
brand name: SODIUM POLYSTYRENE SULFONATE
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEKVK-Tech, Inc.905c3ee5-d1a7-4deb-a345-4a42296704fa2024-02-23Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEEpic Pharma, LLC61cc890b-eb3d-494c-ae45-629a27e721ce2023-11-29Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEChartwell RX, LLCe910a2f9-07ee-4e8f-95bd-f124e1306ff72023-10-05Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepackcae5e7d2-c6ca-485e-963e-1a147e5b11c32023-03-15Warnings, Adverse reactionsName fallback
brand name: SODIUM POLYSTYRENE SULFONATE
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEPuraCap Laboratories, LLC875d5288-db99-4440-8290-d9192bde6eee2022-12-28Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATESUNRISE PHARMACEUTICAL, INC.c73b9661-2378-4336-8be0-098e7c1ae5222022-08-12Warnings, Adverse reactionsName fallback
brand name: SODIUM POLYSTYRENE SULFONATE
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATECMP Pharma, Inc.12d48dcf-07bd-4b06-bd6c-7543f1be83572021-08-15Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATECMP Pharma, Inc.2017bfbe-cda8-46f1-b4f1-9c086c3249a92021-02-01Warnings, Adverse reactionsName fallback
brand name: Sodium Polystyrene Sulfonate
generic name: SODIUM POLYSTYRENE SULFONATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0379Sodium Polystyrene SulfonateSodium Polystyrene SulfonateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0379Sodium Polystyrene SulfonateSodium Polystyrene SulfonateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0379Sodium Polystyrene SulfonateSodium Polystyrene SulfonateWest-Ward Pharmaceuticals Corp.ANDACurrent