Home Applications 040028 Application 040028
Type ANDA
Sponsor PADDOCK LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KIONEX SODIUM POLYSTYRENE SULFONATE SUSPENSION;ORAL, RECTAL 15GM/60ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040028-001 KIONEX SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION / ORAL, RECTAL AA 2007-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040028-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A040028-001 KIONEX 15GM/60ML SUSPENSION / ORAL, RECTAL AA 2007-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040028-001 KIONEX 15GM/60ML SUSPENSION / ORAL, RECTAL AA 2007-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040028-001 KIONEX 15GM/60ML SUSPENSION / ORAL, RECTAL AA 2007-09-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040028-001 KIONEX 15GM/60ML SUSPENSION / ORAL, RECTAL AA 2007-09-17 a50c72e98297…
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 Kionex SODIUM POLYSTYRENE SULFONATE ANI Pharmaceuticals, Inc. 676c3d81-d575-43f6-8748-e04b7c0cafeb 2025-09-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040028 application number: ANDA040028
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0574-2002 Kionex Sodium Polystyrene Sulfonate Paddock Laboratories, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22068 ORIG 2012-06-29