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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A201682-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORAL2013-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A201682-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORAL2013-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A201682-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORAL2013-03-01caaa826d4ba7…
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…

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 4 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.72c97b7f-d945-5106-e053-2a91aa0a9b3b2024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions1bb08103-04ee-47a6-a9ad-290e169feb512024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsc8740506-c679-4c41-a96a-8ddbcddd72c62024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPc6ed6f74-0eca-4f99-8c7e-dd3f56167f012024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions6bd15e74-2ca2-49c8-8c01-0a647d3fa5df2024-01-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsa4aa7f77-c98d-4b70-84bb-e16a06fc79522023-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions88fabecc-6e53-464b-9659-12b2472c89ce2023-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack42942482-1f54-4c7f-9d5f-4aaf20abb3e32023-11-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP8d992a4c-8740-4636-928f-bb808eae33362023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC35099fd1-1bc9-428b-9b9c-71f574cc41562022-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: losartan potassium and hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPa6e7d8a7-f969-4a21-ac28-93c77ed1fa632021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP6dd115b5-9268-4b66-bae8-0aa2605ebbd32021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP198d5151-7982-4639-9fe1-6573a45293482021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP7897d182-2859-4a40-af4d-aaa9d9720fd92021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP33710c3c-6f17-457a-8665-04c23bca8b752019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.