Application 211067

Type
ANDA
Sponsor
APOTEX

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
A211067-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORAL2018-08-08
A211067-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORAL2018-08-08

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORAL2018-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORAL2018-08-0884e616aacf4f…
2026-08-18 06:07:402026-07A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORAL2018-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORAL2018-08-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211067-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2018-08-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211067-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2018-08-0874a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211067-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211067-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211067-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211067-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211067-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211067-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211067-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211067-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211067-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211067-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211067-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211067-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211067-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211067-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211067-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211067-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211067-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211067-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211067-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211067-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211067-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211067-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211067-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211067-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211067-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211067-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211067-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211067-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211067-002AA1782e0a99824c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12A211067-001CGT2019-02-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211067-002CGT2019-03-0674a2ff9319b5…
2019-12-14 00:12 UTC2019-12A211067-001CGT2019-02-253f01610625f2…
2019-12-14 00:12 UTC2019-12A211067-002CGT2019-03-063f01610625f2…
2019-09-15 20:21 UTC2019-09A211067-001CGT2019-02-25b00525d2431f…
2019-09-15 20:21 UTC2019-09A211067-002CGT2019-03-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A211067-001CGT2019-02-25ea99ee380514…
2019-07-19 19:46 UTC2019-07A211067-002CGT2019-03-06ea99ee380514…

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 7 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce2025-01-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ccaaa3a2-a273-41c7-9e54-429539ea01402024-11-19Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEPAI Holdings, LLC dba PAI Pharmae848477f-b10d-4249-b322-b70cd6a062de2024-11-19Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions3a720078-f455-44ab-a883-e3c13d83a74c2024-11-18Warnings, Adverse reactionsName fallback
brand name: potassium chloride
generic name: POTASSIUM CHLORIDE
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutionscf014023-5300-455f-9f7f-fefb2e3639862024-11-18Warnings, Adverse reactionsName fallback
brand name: potassium chloride
generic name: POTASSIUM CHLORIDE
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackf22606a5-ac9f-44fc-bb7b-08f3cf56c9992024-11-12Warnings, Adverse reactionsName fallback
brand name: potassium chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health Packaging96ea00f5-b922-4d57-b2ac-34523ea56d5f2024-10-31Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack55747ef3-9437-4bdc-9ebd-a74d8e2de1cf2024-10-29Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack473369cb-3a9b-437c-b08e-8fb38034c5072024-10-03Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDESomerset Therapeutics, LLC32809eae-1c3f-96fc-e063-6394a90aeaad2024-09-30Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack8bae6f0f-58ca-490f-a725-8ec4bc6ba5142024-09-18Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack863e6980-4a66-48a5-a14f-828a00480c932024-08-23Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAmerican Health Packaging8c12c5f8-5950-44e3-9473-a0b95187b43c2024-08-22Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLC1373321f-533a-4ab4-8bcd-8bde15371a092024-08-13Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack7427c29e-55c1-4c30-b091-058c8bec592f2024-08-12Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf1791d4f-029a-487f-aee1-fc5be246d0bc2024-08-09Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack80dd5de2-5066-472b-b1f8-88070a5c73882024-08-05Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEFresenius Kabi USA, LLC3849b89c-c309-46fb-a1e2-53ff0c65077f2024-07-23Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackb5a6b6f2-d073-4bd3-a66c-bf34ccabfe512024-07-18Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepackd396477a-6b15-4782-9c85-b9663b83c4842024-05-23Warnings, 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7061Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7061Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
48433-217POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
48433-217POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
48433-218POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
48433-218POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55182ORIG2018-08-16