Application 072011

Type
ANDA
Sponsor
SANDOZ

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 42.

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
A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE50MG;75MGTABLET / ORALAB1988-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072011-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-173f01610625f2…
2019-09-15 20:21 UTC2019-09A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072011-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-06-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A072011-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072011-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072011-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072011-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072011-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072011-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072011-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072011-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072011-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072011-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072011-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072011-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072011-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072011-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072011-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072011-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072011-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072011-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072011-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072011-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072011-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072011-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072011-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072011-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072011-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072011-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072011-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072011-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072011-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072011-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072011-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072011-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072011-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072011-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072011-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072011-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072011-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072011-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072011-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072011-001AB1e64feba35796…

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 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEChartwell RX, LLC261dd83f-8048-488f-8b71-c4abd96927202025-12-10Adverse reactionsName fallback
brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.e505484d-b600-4d13-a4b9-278dc4a2e73a2025-10-20Warnings, Adverse reactionsName fallback
brand name: Triamterene and Hydrochlorothiazide

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1008Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideSandoz IncANDACurrent
0781-1008Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideSandoz IncANDACurrent
0781-5067Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideSandoz IncANDACurrent
0781-5067Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideSandoz IncANDACurrent
10544-080Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
21695-496Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideRebel Distributors CorpANDACurrent
43063-442Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-442Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-442Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2489Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3106Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideA-S Medication SolutionsANDACurrent
68001-215Triamterene hydrochlorothiazideTriamterene and hydrochlorothiazideBluePoint LaboratoriesANDACurrent