FDA.reportPublic FDA data

Application 080736

Type
ANDA
Sponsor
LUITPOLD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDEINJECTABLE;INJECTION2MEQ/MLNoNo

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
A080736-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTIONApproved 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 · 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 UTC2022-09A080736-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080736-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080736-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTIONApproved 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 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDECardinal Health 107, LLCea55ded1-e076-43de-ad3c-c75e7d0a4ebc2026-08-24Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE ORALCardinal Health 107, LLCfea3ae21-3395-437e-b773-b180e1c988012026-08-24Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDECoupler LLC598f61d7-a665-5d02-e063-6394a90a89052026-08-21Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEPreferred Pharmaceuticals Inc.3f19ed0e-6c73-482c-94d6-d3205318fd6f2026-08-17Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals LLCf9965f73-e189-423f-bd10-c4a0ed12b4852026-08-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.16c775e4-0dd8-4e9f-b2bf-dd2b639374cf2026-07-31Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEREMEDYREPACK INC.7ec22e8e-6643-44fe-804d-ca0b0b2666632026-07-31Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC02707146-331f-4511-a187-0152fc8bca852026-07-24Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals6c080e51-4eb7-4e96-b29f-eb1cce3813042026-07-14Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEATLANTIC BIOLOGICALS CORP.104ccc91-2aaf-4bb7-bb64-77c29413f60e2026-07-10Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHospira, Inc.559a0a8c-a8fe-40a5-b196-21f9308780ab2026-07-01Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions30527e49-6648-44f3-97b2-9c51783ac0032026-07-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals NY LLC590dd25c-c4cb-489a-a09b-eccbf1d37c1f2026-07-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDESt. Mary's Medical Park Pharmacy549c9d28-bf8b-2dc2-e063-6294a90abe7b2026-06-19Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.f75713cf-6902-4160-94cb-335a1ecdbbbe2026-06-12Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLC548953ac-31c5-a181-e063-6294a90a3b772026-06-12Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDERedpharm Drug5261dfe5-d62b-d618-e063-6294a90a96e72026-05-22Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2e84d34-e042-477f-9944-3fcb953012172026-05-20Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
potassium chloridePOTASSIUM CHLORIDENorthstar Rx LLCb19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a2026-05-18Warnings, Adverse reactionsName fallback
brand name: potassium chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack9088ca44-5585-4551-8e2c-168f306520d42026-03-30Warnings, 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.