Application 201682

Type
ANDA
Sponsor
IPCA LABS 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 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
A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;50MGTABLET / ORAL2013-03-01
A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;100MGTABLET / ORAL2013-03-01
A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM25MG;100MGTABLET / ORAL2013-03-01

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 UTC2026-02A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2013-03-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2013-03-018072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201682-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201682-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201682-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201682-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201682-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201682-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201682-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201682-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201682-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201682-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201682-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201682-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201682-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201682-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201682-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201682-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201682-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201682-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201682-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201682-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201682-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201682-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201682-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201682-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201682-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201682-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201682-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201682-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201682-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201682-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201682-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201682-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201682-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201682-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201682-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201682-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201682-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201682-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201682-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201682-001AB1782e0a99824c…

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.9f9cd7a7-be95-4ea8-8247-eb7ecbd369362026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.ee1eaaf6-050b-48af-942b-5e3451edc1642026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacyeac57b4c-e79b-8d35-e053-2a95a90a9d252026-06-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.cdf59426-2a2f-4a60-943a-e6cef3eb31e12026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.6eab1c0a-9328-42a6-8eae-d4e105c547162026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQPharma Inc8d2e01fe-6d4b-4c13-a03c-77f72b6357152026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQPharma, Inc499208e5-21ab-d4fe-e063-6294a90a9a782026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.03c0ec8d-9daf-43e8-8a4e-a2ddc3573ca72026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.446e6998-01f6-4de0-be57-7fecf5448e952026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.fd07d24c-6db1-4f6b-b226-68abba3a33212026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsbe99cc03-ea65-4b17-bd9e-df7ae43077782026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack59801c48-2af7-4967-ae70-99f865551a7a2026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack1d6712a3-bfb3-4081-b8f6-6057eb4baa272026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd838e918-2463-79f6-e053-2a95a90a948d2026-03-05Warnings, Adverse reactionsName fallback
brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsdc9512cf-db66-40e9-afcb-1d6a722772e82026-02-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions5ec290f4-bf21-4c5b-a576-8eb2bd6bd3792026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDECoupler LLC44fd38d2-cb8b-d0e8-e063-6294a90a994e2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsbc8b9ae2-8263-4624-8629-4f856392f9da2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.deafd195-7a1b-4ad8-a371-2cd9f433dea52025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.acecced9-2a61-435d-b7d4-b151cb7b7e5d2025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide