FDA.reportPublic FDA data

Application 215716

Type
ANDA
Sponsor
QUAGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL20MEQ/15MLNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL40MEQ/15MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215716-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-12-22
A215716-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215716-001AA
A215716-002AA

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
2026-09-14 22:38:342026-08A215716-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-12-2284e616aacf4f…
2026-09-14 22:38:342026-08A215716-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A215716-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A215716-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215716-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215716-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-12-22011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215716-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215716-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215716-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A215716-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A215716-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A215716-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215716-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215716-002AA1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215716-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215716-002AA1a50c72e98297…

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 9 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608a8de-8133-1d4b-e053-2991aa0a907a2023-11-13Name fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron860887e7-7eaf-78c2-e053-2991aa0a9a752023-11-13Name fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron86086aab-c411-7cf2-e053-2991aa0a81bd2023-11-13Name fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608a379-c3b7-3053-e053-2a91aa0a2e652023-11-13Name fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608f3dd-31bf-0182-e053-2991aa0a10302023-11-13Name fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals, Inc.1f33bcfe-c28a-4800-9241-685d974a5d912023-11-08Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoironcaaad470-7be1-11e6-b409-424c583030312023-10-16Name fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionse1670127-c551-441b-bac4-39f10a6d156f2023-09-18Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionsf1af7e05-68ba-438e-a63b-cd8c23960c852023-09-06Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEA-S Medication Solutions0dc6c066-1a59-4798-b9e6-d668722453892023-09-04Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron86099779-8dbd-a9eb-e053-2991aa0ab7a72023-07-20Name fallback
generic name: POTASSIUM CHLORIDE
Potassium chloridePOTASSIUM CHLORIDEANI Pharmaceuticals, Inc.0128a879-7185-4b70-b0bb-d108ff1c95422023-07-20Warnings, Adverse reactionsName fallback
brand name: Potassium chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENexus Pharamaceuticals Inc.765ef38c-df36-46d1-9062-61e30ff46a862023-06-13Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEFresenius Kabi USA, LLCfcd4f458-ce27-417e-9bb6-de1cc49d44b92023-02-27Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions87cc7349-5a07-4a39-be97-4e1013814f302023-02-06Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEGranules Pharmaceuticals Inc.9f8d2886-9ecd-4cbf-a84a-2d221cb3497c2023-01-27Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608d5a3-93e6-e8e2-e053-2a91aa0aaedc2023-01-23Name fallback
generic name: POTASSIUM CHLORIDE
KALI MURIATICUMPOTASSIUM CHLORIDEHyland's Inc.2e8a4762-d28d-4b64-892f-913e04d18d2d2022-12-19WarningsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEZydus Pharmaceuticals (USA) Inc.31e02249-7984-4b8f-9e37-2b79b708ac082022-10-18Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEZydus Lifesciences Limited099c3a36-f460-4191-80e5-0c4153a5c7132022-10-18Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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