Application 202289

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;50MGNoNo
002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;100MGNoNo
003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL25MG;100MGNoNo

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
A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;50MGTABLET / ORALAB2012-08-09
A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;100MGTABLET / ORALAB2012-08-09
A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM25MG;100MGTABLET / ORALAB2012-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202289-001AB
A202289-002AB
A202289-003AB

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 06:07:402026-07A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202289-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2012-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202289-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2012-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202289-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2012-08-091e350fbaab3a…

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 06:07:402026-07A202289-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202289-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202289-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202289-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202289-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202289-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202289-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202289-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202289-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202289-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202289-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202289-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202289-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202289-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202289-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202289-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202289-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202289-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202289-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202289-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202289-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202289-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202289-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202289-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202289-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202289-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202289-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202289-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202289-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202289-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202289-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202289-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202289-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202289-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202289-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202289-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202289-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202289-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202289-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202289-001AB11e350fbaab3a…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf5f462c6-0604-49d3-af8f-fecbde23be992025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202289
application number: ANDA202289
Losartan potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limiteda04b5622-2c49-4d61-92b1-5dc523af7a242025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202289
application number: ANDA202289
ndc (product): 33342-051
ndc (product): 33342-052
ndc (product): 33342-050
Losartan potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack352061ee-942d-6cba-e063-6294a90a9eea2025-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202289
application number: ANDA202289
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd1ed9593-a587-55bb-e053-2995a90a8a9a2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202289
application number: ANDA202289
ndc (product): 72189-289
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd1ee193e-bf78-3134-e053-2a95a90a65d22025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202289
application number: ANDA202289
ndc (product): 72189-290
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd2021060-94d7-3e1d-e053-2995a90a10ee2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202289
application number: ANDA202289
ndc (product): 72189-297

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-050Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-050Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-050Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-051Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-051Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-051Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-052Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-052Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-052Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
70518-3231Losartan potassium and HydrochlorothiazideLosartan potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
72189-289LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxANDACurrent
72189-290LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxANDACurrent
72189-297LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxANDACurrent