Application 210733

Type
ANDA
Sponsor
STRIDES PHARMA

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 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
A210733-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31
A210733-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210733-001AB2
A210733-002AB2

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210733-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210733-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22018-08-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210733-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A210733-002AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210733-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210733-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210733-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210733-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210733-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210733-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210733-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210733-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210733-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210733-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210733-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210733-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210733-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210733-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210733-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210733-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210733-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210733-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210733-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210733-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210733-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210733-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210733-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210733-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210733-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210733-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210733-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210733-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210733-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210733-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210733-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210733-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210733-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210733-002AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210733-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210733-002AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210733-001AB21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210733-002AB21bb7c543d1eb4…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210733
application number: ANDA210733
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limited0224e5b3-3c49-4e6e-aa78-1abcc69692462025-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210733
application number: ANDA210733
ndc (product): 64380-861
ndc (product): 64380-860
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepackab147ac2-d7d5-46d1-a2de-d866219197c12025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210733
application number: ANDA210733
ndc (product): 71335-1131
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDirect_Rx946b9568-671d-172a-e053-2a95a90ac8272025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210733
application number: ANDA210733
ndc (product): 72189-027

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
53002-2034Potassium ChloridePotassium ChlorideRPK Pharmaceuticals, Inc.ANDACurrent
60687-708Potassium ChloridePotassium ChlorideAmerican Health PackagingANDACurrent
63629-8115Potassium ChloridePotassium ChlorideBryant Ranch PrepackANDACurrent
64380-860Potassium ChloridePotassium ChlorideStrides Shasun LimitedANDACurrent
64380-860Potassium ChloridePotassium ChlorideStrides Pharma Science LimitedANDACurrent
64380-861Potassium ChloridePotassium ChlorideStrides Shasun LimitedANDACurrent
64380-861Potassium ChloridePotassium ChlorideStrides Pharma Science LimitedANDACurrent
67296-1771Potassium ChloridePotassium ChlorideRedPharm Drug, Inc.ANDACurrent
67296-1771Potassium ChloridePotassium ChlorideRedPharm Drug, Inc.ANDACurrent
68071-5002Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5002Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2219Potassium ChloridePotassium ChlorideREMEDYREPACK INC.ANDACurrent
70518-2219Potassium ChloridePotassium ChlorideREMEDYREPACK INC.ANDACurrent
70934-443Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-443Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-747Potassium ChloridePotassium ChlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1131Potassium ChloridePotassium ChlorideBryant Ranch PrepackANDACurrent
71335-1131Potassium ChloridePotassium ChlorideBryant Ranch PrepackANDACurrent
72189-027POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDirect_RxANDACurrent
72189-027POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDirect_RxANDACurrent