Application 089421

Type
ANDA
Sponsor
WATSON LABS

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
A089421-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02

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 22:38:342026-08A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-0284e616aacf4f…
2026-08-18 06:07:402026-07A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-023f01610625f2…
2019-09-15 20:21 UTC2019-09A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089421-001POTASSIUM CHLORIDE2MEQ/MLINJECTABLE / INJECTION1987-01-02f41ea6bd6efb…

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 8 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEXLCare Pharmaceuticals, Inc.7fd82f08-8ad0-4ee2-8eb6-5c973f98baee2024-05-21Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack7a220e87-ff72-417b-bc45-90a37b7f2aa62024-05-21Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDECamber Pharmaceuticals, Inc.b1e827aa-b2fb-4fa5-984d-ddd94338ff532024-05-14Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC55d9ae37-4553-47e7-a2e3-86b48b5227cd2024-05-08Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepack65e30d1a-50e9-4b84-ad4d-daaea91eab4b2024-04-09Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC7c5cc705-e5da-4487-86c9-9d545a95afb42024-03-22Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEKesin Pharma Corporation25c2b417-eeea-4ba6-8eb9-a7d8a08c60932024-03-12Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP61daa681-05a0-4b2f-a6d0-c6fc1044f5212024-02-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.fe08221d-74d5-490a-8db4-eaf3ed20b2892024-01-30Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packaginga67f5ba7-ac23-4bdc-9563-cb7fd049a9512024-01-22Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.4d90d03d-7f0e-4d49-9e80-628dbc7165c02024-01-10Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.8ed8ea55-8b15-f718-e053-2a95a90a587a2024-01-10Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEProficient Rx LPd0ce0bdf-5f24-4093-813f-881c61d7fcc72024-01-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAdare Pharmaceuticals Inc22edb0e6-4e45-4e91-aead-3581cca293a02023-12-20Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5aa0adf8-7b84-4cb0-be31-5c3333a6cc442023-12-11Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5c4b0be5-625e-435f-9d2c-9d8fb407a8ea2023-12-05Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionsd033c3b3-3ed6-4f23-a555-bae40cf0c48f2023-12-05Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.0a1f2f64-3b0b-5e5c-e063-6294a90a71852023-11-14Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron86093c75-6de0-bb16-e053-2991aa0ab6ef2023-11-13Name fallback
generic name: POTASSIUM CHLORIDE
Kali muriaticumPOTASSIUM CHLORIDEBoiron86090ebb-0fb2-2c9c-e053-2a91aa0a05612023-11-13Name fallback
generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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