FDA.reportPublic FDA data

Application 074701

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENECAPSULE;ORAL25MG;37.5MGNoNo

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
A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGCAPSULE / ORAL1996-06-07

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074701-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074701-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074701-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074701-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074701-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074701-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074701-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074701-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074701-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074701-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074701-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074701-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074701-001AB1ea99ee380514…

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 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.5ee165a3-39a4-4d12-aff2-a6fb3309ce392026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2026-09-03Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDESandoz Incf824b6ba-bd1c-41a8-8f6f-ad507b48f3e02026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.f083c321-3170-4982-b5cd-d3fdff7548572026-07-08Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LP4bc374e2-8650-41bc-8ce6-92062661bf8a2026-07-01Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC0de72197-607f-ef0a-e063-6394a90a89492026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC03b11335-2e88-2f7b-e063-6394a90afe2a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.43425ec7-a2c0-41d8-b759-b7b5918949ce2026-06-01Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacyde5e7c85-5bf5-5b5f-e053-2995a90a1fba2026-06-01Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf3bc491a-961d-4a38-8a55-c4a03be05b742026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke7c34985-a8be-45d3-9273-2b13e2f6b7b22026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.bdd4348d-928d-ef0b-e053-2a95a90aadb42026-02-20Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEApotex Corp.bd6c3495-ec70-908b-482a-a979506659e92026-02-17Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.9fe534cd-cf5f-64b4-e053-2995a90a926e2026-02-12Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.6c4cd90b-44c0-4da5-8f26-f0fa465acce42026-01-13Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAdvagen Pharma Ltda5525a2a-d2c7-411b-9ffc-0cc4fe77f7c72026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf32b8809-80e9-18f2-e053-2995a90a54282026-01-01Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC9ec3d35f-b25d-48f4-926f-f093e402ccde2026-01-01Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb895e64-3f97-9201-e053-2a95a90ac7ef2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC08f3885e-dfde-79e4-e063-6394a90a4c092025-12-26Boxed warning, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2537Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-2537Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-2537Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0615-1333Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
49999-066Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
51079-935Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideMylan Institutional Inc.ANDACurrent
51079-935Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideMylan Institutional Inc.ANDACurrent
71335-1039Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1039Triamterene and Hydrochlorothiazidetriamterene and hydrochlorothiazideBryant Ranch PrepackANDACurrent