Application 090382

Type
ANDA
Sponsor
STRIDES PHARMA

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 42.

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
A090382-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A090382-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A090382-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090382-001AB
A090382-002AB
A090382-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-061e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090382-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090382-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090382-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090382-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090382-001AB11e350fbaab3a…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.4d60e755-40a6-4187-b09e-e55c735945aa2026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 72789-282
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.372ba4ad-26ca-4675-8475-4b664fbecba92026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 72789-163
ndc (product): 72789-164
ndc (product): 72789-165
LOSARTAN POTASSIUM 50 mgLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.498f26a1-5030-4f9b-9599-07d50e912d412026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 72789-179
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMStrides Pharma Science Limiteda8817f22-8478-49b9-8354-ab27ca222c6b2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 64380-935
ndc (product): 64380-934
ndc (product): 64380-933
LOSARTAN POTASSIUM 50 mgLOSARTAN POTASSIUMNorthwind Health Company, LLCc29d999d-adc9-6c66-e053-2995a90a1fc32026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 51655-418
LOSARTAN POTASSIUM 100 mgLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.a955160f-3c2d-3366-e053-2a95a90a65ea2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 68071-2203
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMProficient Rx LPe8075254-cdfd-44f3-a9c2-1ed913f846ea2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 71205-675
LOSARTAN POTASSIUM 50 mgLOSARTAN POTASSIUMProficient Rx LPf260f7c5-a55b-4294-ae02-2586929e24c92021-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090382
application number: ANDA090382
ndc (product): 71205-598

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-644LOSARTAN POTASSIUMLOSARTAN POTASSIUMHeritage Pharmaceuticals Inc.ANDACurrent
23155-644LOSARTAN POTASSIUMLOSARTAN POTASSIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-645LOSARTAN POTASSIUMLOSARTAN POTASSIUMHeritage Pharmaceuticals Inc.ANDACurrent
23155-645LOSARTAN POTASSIUMLOSARTAN POTASSIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-646LOSARTAN POTASSIUMLOSARTAN POTASSIUMHeritage Pharmaceuticals Inc.ANDACurrent
23155-646LOSARTAN POTASSIUMLOSARTAN POTASSIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
50090-2908LosartanLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4048LOSARTAN POTASSIUMLOSARTAN POTASSIUMA-S Medication SolutionsANDACurrent
50090-4048LOSARTAN POTASSIUMLOSARTAN POTASSIUMA-S Medication SolutionsANDACurrent
50090-5337LOSARTAN POTASSIUMLOSARTAN POTASSIUMA-S Medication SolutionsANDACurrent
50090-5338LOSARTAN POTASSIUMLOSARTAN POTASSIUMA-S Medication SolutionsANDACurrent
50090-5406LOSARTAN POTASSIUMLOSARTAN POTASSIUMA-S Medication SolutionsANDACurrent
50090-5406LOSARTAN POTASSIUMLOSARTAN POTASSIUMA-S Medication SolutionsANDACurrent
51655-418LOSARTAN POTASSIUMLOSARTAN POTASSIUMNorthwind PharmaceuticalsANDACurrent
62980-501LOSARTAN POTASSIUMLOSARTAN POTASSIUMVivimed Labs LimitedANDACurrent
62980-502LOSARTAN POTASSIUMLOSARTAN POTASSIUMVivimed Labs LimitedANDACurrent
62980-503LOSARTAN POTASSIUMLOSARTAN POTASSIUMVivimed Labs LimitedANDACurrent
64380-933LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma Science LimitedANDACurrent
64380-933LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma Science LimitedANDACurrent
64380-933LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma IncANDACurrent
64380-934LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma Science LimitedANDACurrent
64380-934LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma Science LimitedANDACurrent
64380-934LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma IncANDACurrent
64380-935LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma Science LimitedANDACurrent
64380-935LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma Science LimitedANDACurrent
64380-935LOSARTAN POTASSIUMLOSARTAN POTASSIUMStrides Pharma IncANDACurrent
66116-415Losartan PotassiumLosartan PotassiumMedVantx, Inc.ANDACurrent
68071-2203LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2203LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2205LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2205LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2205LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5146LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5146LOSARTAN POTASSIUMLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ANDACurrent
69543-141LosartanLosartan PotassiumVirtus PharmaceuticalsANDACurrent
70518-2530LOSARTAN POTASSIUMLOSARTAN POTASSIUMREMEDYREPACK INC.ANDACurrent
70518-2530LOSARTAN POTASSIUMLOSARTAN POTASSIUMREMEDYREPACK INC.ANDACurrent
70518-2530LOSARTAN POTASSIUMLOSARTAN POTASSIUMREMEDYREPACK INC.ANDACurrent
70934-659LOSARTAN POTASSIUMLOSARTAN POTASSIUMDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-781LOSARTAN POTASSIUMLOSARTAN POTASSIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-598LOSARTAN POTASSIUMLOSARTAN POTASSIUMProficient Rx LPANDACurrent
71205-675LOSARTAN POTASSIUMLOSARTAN POTASSIUMProficient Rx LPANDACurrent
71335-1082LOSARTAN POTASSIUMLOSARTAN POTASSIUMBryant Ranch PrepackANDACurrent
72789-163LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-163LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-164LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-164LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-165LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-165LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-179LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-179LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-282LOSARTAN POTASSIUMLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent