Application 071851

Type
ANDA
Sponsor
WATSON LABS

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
A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE50MG;75MGTABLET / ORALAB1988-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071851-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-3084e616aacf4f…
2026-08-18 06:07:402026-07A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071851-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-11-30f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A071851-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A071851-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071851-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071851-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071851-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071851-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071851-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071851-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071851-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071851-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071851-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071851-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071851-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071851-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071851-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071851-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071851-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071851-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071851-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071851-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071851-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071851-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071851-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071851-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071851-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071851-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071851-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071851-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071851-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071851-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071851-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071851-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071851-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071851-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071851-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071851-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071851-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071851-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071851-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071851-001AB1f41ea6bd6efb…

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.860bed38-26f2-49bb-9dba-8928cec3c42c2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071851
application number: ANDA071851
ndc (product): 55289-488
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.7e7cb50d-c984-5c01-e053-2a91aa0a68a52024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071851
application number: ANDA071851
ndc (product): 68071-4687
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack4c74bc01-1065-79f0-f9c4-044ead38a55d2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071851
application number: ANDA071851
ndc (product): 63629-2585
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEActavis Pharma, Inc.abf2fe45-8b69-4d3c-981e-289c0aa3e98b2024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071851
application number: ANDA071851
ndc (product): 0591-0348
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratoriesb8a55c23-b509-4790-88fa-9dc9bacd4bbe2024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071851
application number: ANDA071851
ndc (product): 68001-388
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions0eaf3aa9-7544-4717-944b-ec66af80770e2023-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071851
application number: ANDA071851
ndc (product): 50090-1834

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0348Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideActavis Pharma, Inc.ANDACurrent
0591-0348Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideActavis Pharma, Inc.ANDACurrent
0591-0348Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideActavis Pharma, Inc.ANDACurrent
10544-537Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
33261-365Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
50090-1834Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1834Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1834Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
51655-631TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Pharmaceuticals, LLCANDACurrent
51655-631Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNorthwind PharmaceuticalsANDACurrent
51655-631Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNorthwind PharmaceuticalsANDACurrent
53808-0804Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEState of Florida DOH Central PharmacyANDACurrent
55289-488Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, InANDACurrent
55289-488Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-488Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-488Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-488Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-488Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-2585Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2585Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2585Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8191Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8191Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
68001-388Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68001-388Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68071-4687Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4687Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4687Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9792Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70934-462Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent