FDA.reportPublic FDA data

Application 083345

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDEINJECTABLE;INJECTION1.5MEQ/MLNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDEINJECTABLE;INJECTION2MEQ/MLNoNo
003POTASSIUM CHLORIDEPOTASSIUM CHLORIDEINJECTABLE;INJECTION1MEQ/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083345-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE1.5MEQ/MLINJECTABLE / INJECTIONApproved before 1982
A083345-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTIONApproved before 1982
A083345-003POTASSIUM CHLORIDEPOTASSIUM CHLORIDE1MEQ/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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A083345-001POTASSIUM CHLORIDE1.5MEQ/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A083345-002POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A083345-003POTASSIUM CHLORIDE1MEQ/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 11 · 206 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 CHLORIDEGlenmark Pharmaceuticals Inc., USA63bedd99-0596-49d2-ad04-d1d8ac15cc422026-07-08Warnings, 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
Potassium ChloridePOTASSIUM CHLORIDEAjenat Pharmaceuticals LLCab066a84-5455-419e-a1da-354a3f15a73d2026-03-23Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackff44dcd5-b255-4d80-83ee-3c8f922c99eb2026-03-11Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals of New York LLCcd56e147-92d6-46ce-ae00-63fac08d49b52026-03-03Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions2d67fc67-c99f-4df2-a1e7-4d369cce12c22026-02-23Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEREMEDYREPACK INC.7ec22e8e-6643-44fe-804d-ca0b0b2666632026-02-17Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.16c775e4-0dd8-4e9f-b2bf-dd2b639374cf2026-02-13Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE