FDA.reportPublic FDA data

Application 071980

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENETABLET;ORAL50MG;75MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE50MG;75MGTABLET / ORAL1988-04-17

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-1784e616aacf4f…
2026-08-18 06:07:402026-07A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071980-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORAL1988-04-17f41ea6bd6efb…

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 3 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEActavis Pharma, Inc.abf2fe45-8b69-4d3c-981e-289c0aa3e98b2024-05-01Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.cba87d5b-9302-7b2c-e053-2a95a90a7f9d2024-04-17Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ca13106-f68b-4894-aca2-03e74fff350c2024-04-03Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratoriesb8a55c23-b509-4790-88fa-9dc9bacd4bbe2024-03-29Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsd3dce0c7-9e5f-49f8-bcc2-1919a30565fd2024-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsd692b189-1b06-46f5-a257-758a7dede8632024-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack6517777a-e49e-4da6-b34b-66ec58cceff72024-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions0eaf3aa9-7544-4717-944b-ec66af80770e2023-12-10Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions839216fd-5eac-4550-8baa-ad77b91c5de72023-11-24Boxed warning, Adverse reactionsName fallback
brand name: triamterene and hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc9925ab75-e3b7-43b7-888e-a2c8763240ba2023-10-31Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions27b8f965-d73f-411c-aae6-bcae6e2811132023-10-23Boxed warning, Adverse reactionsName fallback
brand name: triamterene and hydrochlorothiazide
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limited1af80800-e7a5-42e5-aa6c-3f61aff4a77b2023-08-31Boxed warning, Adverse reactionsName fallback
brand name: triamterene and hydrochlorothiazide
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEZydus Pharmaceuticals (USA) Inc.fa69eeb8-ec82-4be1-8cb7-f64094ed957c2023-08-26Boxed warning, Adverse reactionsName fallback
brand name: triamterene and hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8cc154c2-2ed2-4d7c-95a5-e2946393270c2023-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC15e6f934-fe66-4640-bdf1-13b389cd9e542023-01-04Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LP189ad040-07e9-42a5-854c-67633367da742023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCb129e54a-a6d8-42c0-baac-e8db2487369b2021-11-05Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC236dead0-16d5-4383-860f-30743730a0882021-10-28Boxed warning, Adverse reactionsName fallback
brand name: triamterene and hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LPf11598d2-87ee-4292-8631-c29c54f4dfa92021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC191b9e48-7d44-4378-9f3f-b4a999080c8c2020-11-12Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

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