Application 087787

Type
ANDA
Sponsor
ABRAXIS PHARM

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
A087787-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-2084e616aacf4f…
2026-08-18 06:07:402026-07A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-203f01610625f2…
2019-09-15 20:21 UTC2019-09A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087787-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1982-04-20f41ea6bd6efb…

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 10 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories73c911bb-4d39-4793-acba-90ed4b0eff462022-10-17Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDr. Reddys Laboratories, Inc.dda82a38-0c08-4947-99b7-915c2949bf162022-08-29Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEActavis Pharma, Inc.db002ae3-f54c-40a4-9cb4-e5681bf426e32022-08-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEActavis Pharma, Inc.ed5baaf6-270b-4dd3-b100-36030c0098fc2022-08-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
KALIUM MURIATICUM 6XPOTASSIUM CHLORIDESeroyal USA22c95b6a-dd5d-476e-e054-00144ff8d46c2022-07-07WarningsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEB. Braun Medical Inc.ab67b151-8368-4321-b562-bad5eff7b7402022-02-21Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDETris Pharma Inc159ddd0b-847e-4ecc-b3b2-9634cbb4dfa92022-01-26Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEGuardian Drug Company3d460e84-27a0-485c-8b11-58d03d9064aa2021-07-28Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAurobindo Pharma Limiteddeb6b462-397f-4527-ae26-40dc5d5857bc2021-04-30Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAurobindo Pharma Limitedd43beabe-b801-4319-ad36-9a80856b94bd2021-04-29Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
potassium chloridePOTASSIUM CHLORIDEZydus Pharmaceuticals (USA) Inc.51586c47-1aff-4ce6-8030-89f9eb1bc9ac2021-02-08Warnings, Adverse reactionsName fallback
brand name: potassium chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.28c49165-d8c9-443a-b000-953b8e1ec55c2020-11-20Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences Inc.23d818e7-c076-40de-8dc1-0b51ba4be96a2020-04-28Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.1bbacdbb-91fa-4897-a00c-1b293de27b832020-04-27Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEMylan Pharmaceuticals Inc.c64ed4c0-1e27-42b3-9625-fb4e0d31e2712020-04-15Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories431ff2ef-567c-4b60-af43-f4da61febaad2019-07-03Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE EXTENDED-RELEASESolco Healthcare LLCf704b746-ab75-4484-8704-5baa94a077502019-04-30Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENovel Laboratories, Inc.ce4d4d39-8551-4789-8347-af763635922c2018-11-28Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCdded25a9-3df4-463a-8685-d2bc03ea4edb2018-07-16Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEGlenmark Pharmaceuticals Inc., USA5b054142-7372-4641-be27-dca630a97ad92016-04-29Warnings, 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.