Application 090467

Type
ANDA
Sponsor
TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL25MGNoNo
002LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL50MGNoNo
003LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090467-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06
A090467-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06
A090467-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090467-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090467-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090467-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-10-068072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090467-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090467-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090467-003AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A090467-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090467-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090467-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090467-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090467-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090467-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090467-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090467-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090467-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090467-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090467-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090467-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090467-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090467-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090467-003AB1ea99ee380514…

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 7 · 140 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.df4f55f0-fb11-4f6f-a7ed-127b50f955fc2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMZydus Pharmaceuticals USA Inc.3233c707-70b6-4c29-8210-913eeb2a38ed2026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.f7cf8a7d-90f1-46a3-abff-1eb316aa7d722026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTANPreferred Pharmaceuticals Inc.9501dfaa-c8cf-46d6-8bec-936c4fd8fe032026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.6f39f7f9-edac-45ca-9ee2-c2ecad0915ab2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.1843ee4b-1afc-4992-993a-4b0e03e785fc2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.9b3ddaa2-a835-736a-e053-2995a90aff082026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.25c93638-7016-47d2-a57c-e4a5245ca41b2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMUnit Dose Solutions, Inc.5529733c-1e3b-e590-e063-6294a90a765c2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMUnit Dose Solutions, Inc.552a2f78-6318-310f-e063-6394a90abb152026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.41069514-0491-41fe-b7fe-a52d42d338482026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMAmerican Health Packaginge7f6b25b-ec4c-4c3a-a541-617d2d9ab3932026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.45c01cc9-c7d1-4bb6-a105-354fc936ec632026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMCoupler LLC53e82c07-fe4c-78db-e063-6394a90a80872026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan potassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.628d0317-b844-42a0-9c27-48e1e23a38f52026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMSt. Mary's Medical Park Pharmacyaaf943ff-d6af-8ce2-e053-2995a90a7b762026-06-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMCardinal Health 107, LLCb83d896a-c7e9-4508-814c-425b88a87b162026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack0f3a6984-e601-4a74-9910-49ee5e352d6b2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMCoupler LLC53456224-db79-e7c1-e063-6394a90a90d52026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.c4b81f90-bcd0-45d0-99ce-35ca998d473a2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 130 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-1684Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1986Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3102Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3293Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3301Losartan PotassiumLosartan PotassiumNuCarePharmaceuticals, Inc.ANDACurrent
68071-3301Losartan PotassiumLosartan PotassiumNuCarePharmaceuticals, Inc.ANDACurrent
68071-3301Losartan PotassiumLosartan PotassiumNuCarePharmaceuticals, Inc.ANDACurrent
68071-4019Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4046Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4058Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4059Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4141Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4141Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68151-0182Losartan PotassiumLosartan PotassiumCarilion Materials ManagementANDACurrent
68645-494Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-0048Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0048Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0048Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6788Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9986Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9986Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9986Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0087Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0087Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0087Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0087Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0087Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0189Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0189Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0189Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0586Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0586Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0588Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0588Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0588Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
71205-069Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-069Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-102Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-102Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71335-0181Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0181Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0181Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0181Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0249Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0249Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0442Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0442Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71610-230Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-260Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
75921-409Losartan PotassiumLosartan PotassiumLife Line Home Care Services, Inc.ANDACurrent