Application 205993

Type
ANDA
Sponsor
PADDOCK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL8MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQNoNo

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
A205993-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05
A205993-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205993-001AB2
A205993-002AB2

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 22:38:342026-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205993-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A205993-002AB2184e616aacf4f…
2026-08-18 06:07:402026-07A205993-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A205993-002AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205993-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205993-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002AB2174a2ff9319b5…

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 2 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 CHLORIDEPOTASSIUM CHLORIDEMajor Pharmaceuticals33ad1eb2-1f05-461c-b01d-82dee42315562026-02-11Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals5c2e888c-2f1e-4d5a-a456-20774ca833022026-02-04Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEMajor Pharmaceuticals7d74652b-3513-4ebb-8b47-10b3603d04a72026-02-04Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDERising Pharma Holdings, Inc.947c11ca-ca0c-42df-8cc5-3db06458ca5b2026-02-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POKONZA potassium chloridePOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC2d938cbf-27aa-4f9c-a582-5564d3b724652026-01-22Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAvKARE755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c62026-01-15Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAdvagen Pharma Limitedd528c0c1-b81f-4f7a-8518-e6911b23c3eb2026-01-13Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Sore Throat 911POTASSIUM CHLORIDEDelCorean, LLC9ff8ff03-5921-cb3c-e053-2a95a90a094b2026-01-13WarningsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAvPAKf32df7c0-33eb-e6d6-e053-2a95a90a2e8d2026-01-09Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare Corporation092ddee4-572d-4771-8d95-880cea01097e2026-01-09Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Limiteda9e9d134-55d0-47ae-925f-de07e7ffa4b82026-01-07Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Ltd.f4497c26-da16-45b0-975d-81f2c21327042026-01-07Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23b10bd6-11bc-495e-bb05-ec332a9b3f212026-01-06Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCf2b671c9-9874-2668-e053-2a95a90a1b462026-01-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCf3081031-8234-5732-e053-2995a90aebeb2026-01-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCdae7c63d-eef0-58d0-e053-2a95a90a667e2026-01-01Warnings, 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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0274Potassium chloride extended releasePotassium chloridePaddock Laboratories, LLCANDACurrent
0574-0274Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
0574-0274Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
0574-0275Potassium chloride extended releasePotassium chloridePaddock Laboratories, LLCANDACurrent
0574-0275Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
0574-0275Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal HealthANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal HealthANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal Health 107, LLCANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal HealthANDACurrent
63629-8442Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8442Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8442Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8443Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8443Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8443Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8700Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8700Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8700Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
70518-2291Potassium chloride extended releasePotassium chlorideREMEDYREPACK INC.ANDACurrent
71205-996Potassium chloride extended releasePotassium chlorideProficient Rx LPANDACurrent
71205-996Potassium chloride extended releasePotassium chlorideProficient Rx LPANDACurrent