Application 201407

Type
ANDA
Sponsor
LANNETT CO INC

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 1.

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
A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGCAPSULE / ORALAB2011-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201407-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093f01610625f2…
2019-09-15 20:21 UTC2019-09A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201407-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201407-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201407-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201407-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201407-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201407-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201407-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201407-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201407-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201407-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201407-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201407-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201407-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201407-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201407-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201407-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201407-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201407-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201407-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201407-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201407-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201407-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201407-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201407-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201407-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201407-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201407-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201407-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201407-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201407-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201407-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201407-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201407-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201407-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201407-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201407-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201407-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201407-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201407-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201407-001AB1cb3db0bc1861…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEChartwell RX, LLC261dd83f-8048-488f-8b71-c4abd96927202025-12-10Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsd692b189-1b06-46f5-a257-758a7dede8632024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
ndc (product): 50090-2028
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack6517777a-e49e-4da6-b34b-66ec58cceff72024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
ndc (product): 71335-0504
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8cc154c2-2ed2-4d7c-95a5-e2946393270c2023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LP189ad040-07e9-42a5-854c-67633367da742023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
ndc (product): 63187-905

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1632Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLannett Company, Inc.ANDACurrent
0527-1632Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLannett Company, Inc.ANDACurrent
0527-1632Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLannett Company, Inc.ANDACurrent
0527-1632Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLannett Company, Inc.ANDACurrent
0527-1632Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLannett Company, Inc.ANDACurrent
10135-581Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMarlex Pharmaceuticals IncANDACurrent
10135-581Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMarlex Pharmaceuticals IncANDACurrent
42291-841Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAvKARE, Inc.ANDACurrent
42291-841Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAvKAREANDACurrent
42291-841Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAvKAREANDACurrent
50090-2028Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2028Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2028Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
53002-1246Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1246Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideRPK Pharmaceuticals, Inc.ANDACurrent
55700-582Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-582Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-582Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-535Triamterene and HydrochlorothiazideTriamterene, HydrochlorothiazideSt. Mary's Medical Park PharmacyANDACurrent
60760-535Triamterene and HydrochlorothiazideTriamterene, HydrochlorothiazideSt. Mary's Medical Park PharmacyANDACurrent
63187-905Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideProficient Rx LPANDACurrent
63187-905Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideProficient Rx LPANDACurrent
63187-905Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideProficient Rx LPANDACurrent
66267-510Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-510Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3080Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3080Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3080Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3080Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6802Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred PharmaceuticalsANDACurrent
68788-6802Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
71335-0504Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0504Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0504Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent