Application 214452

Type
ANDA
Sponsor
GRANULES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL20MEQNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214452-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21
A214452-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214452-001AB1
A214452-002AB1

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214452-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A214452-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214452-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214452-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214452-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214452-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214452-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214452-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214452-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214452-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214452-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214452-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214452-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214452-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214452-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214452-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214452-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214452-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214452-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214452-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214452-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A214452-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214452-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214452-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214452-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214452-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214452-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214452-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214452-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214452-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214452-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214452-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214452-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214452-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214452-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214452-002AB114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214452-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214452-002AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214452-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A214452-002AB11782e0a99824c…

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 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.2c407aaf-5d95-49ff-a5db-f1d7b51903342026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASERedpharm Drug37455920-e408-5906-e063-6294a90a57ae2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEAtlantic Biologicals Corp.4d7ad5c6-2c18-dc29-e063-6394a90a621e2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.ace1eb11-b925-405a-b772-58c60b3ca7d42025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules India Ltd60285a8d-bcb0-40ba-b359-df5c89480cd62025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 62207-727
ndc (product): 62207-726
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx42c92fcc-21d2-d32a-e063-6294a90a83122025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBluepoint Laboratoriesd605ca36-2bfa-42cb-a46c-8ecb3162994e2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 68001-566
ndc (product): 68001-567
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsde335131-bb8a-44e5-89fa-1478edbcdc0e2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsedb6c987-e2c3-421f-8a8d-849c9e17ace82025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules Pharmaceuticals Inc.b3d4d5b5-2898-ae3d-e053-2a95a90a6d042025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 70010-136
ndc (product): 70010-135
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEPreferred Pharmaceuticals Inc.87f369cf-40e5-4f91-aa42-ae986fce65442025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 68788-8196
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx377854ff-8034-c7ac-e063-6294a90a08172025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDE EXTENDED-RELEASENCS HealthCare of KY, LLC dba Vangard Labsc684758c-16f0-4bd9-b719-1aae64b7907f2025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 0615-8400
ndc (product): 0615-8399
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPf191b15c-7959-4aa6-a2ef-617cde77c9182024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepackb5505a39-57f1-4ed5-b845-4f1d8aa109502024-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepack7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 71335-1896
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPc53d1db5-1c9e-4289-a2a2-961e0dd56f322024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8399Potassium Chloride Extended-releasePotassium Chloride Extended-releaseNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8400Potassium Chloride Extended-releasePotassium Chloride Extended-releaseNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-7201Potassium Chloride Extended-releasePotassium Chloride Extended-releaseMajor PharmaceuticalsANDACurrent
0904-7202Potassium Chloride Extended-releasePotassium Chloride Extended-releaseMajor PharmaceuticalsANDACurrent
62207-726Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
62207-726Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
62207-727Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
62207-727Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
68001-566Potassium Chloride Extended-releasePotassium Chloride Extended-releaseBluepoint LaboratoriesANDACurrent
68001-567Potassium Chloride Extended-releasePotassium Chloride Extended-releaseBluepoint LaboratoriesANDACurrent
68788-8196Potassium Chloride Extended-releasePotassium Chloride Extended-releasePreferred Pharmaceuticals Inc.ANDACurrent
70010-135Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70010-135Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70010-136Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70010-136Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70518-3521Potassium Chloride Extended-releasePotassium Chloride Extended-releaseREMEDYREPACK INC.ANDACurrent
70518-3521Potassium Chloride Extended-releasePotassium Chloride Extended-releaseREMEDYREPACK INC.ANDACurrent
71335-1896Potassium Chloride Extended-releasePotassium Chloride Extended-releaseBryant Ranch PrepackANDACurrent