Application 017105

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANXENECLORAZEPATE DIPOTASSIUMCAPSULE;ORAL3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002TRANXENECLORAZEPATE DIPOTASSIUMCAPSULE;ORAL7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
003TRANXENECLORAZEPATE DIPOTASSIUMCAPSULE;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
004TRANXENE SDCLORAZEPATE DIPOTASSIUMTABLET;ORAL22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
005TRANXENE SDCLORAZEPATE DIPOTASSIUMTABLET;ORAL11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
006TRANXENECLORAZEPATE DIPOTASSIUMTABLET;ORAL3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
007TRANXENECLORAZEPATE DIPOTASSIUMTABLET;ORAL7.5MGYesNo
008TRANXENECLORAZEPATE DIPOTASSIUMTABLET;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017105-001TRANXENECLORAZEPATE DIPOTASSIUM3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017105-002TRANXENECLORAZEPATE DIPOTASSIUM7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017105-003TRANXENECLORAZEPATE DIPOTASSIUM15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017105-004TRANXENE SDCLORAZEPATE DIPOTASSIUM22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017105-005TRANXENE SDCLORAZEPATE DIPOTASSIUM11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017105-006TRANXENECLORAZEPATE DIPOTASSIUM3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017105-007TRANXENECLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALABRLD, Approved before 1982
N017105-008TRANXENECLORAZEPATE DIPOTASSIUM15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017105-007AB

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 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…

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 UTC2026-02N017105-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017105-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017105-007AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017105-007AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017105-007AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017105-007AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017105-007AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017105-007AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017105-007AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017105-007AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017105-007AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017105-007AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017105-007AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017105-007AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017105-007AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017105-007AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017105-007AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017105-007AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017105-007AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017105-007AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017105-007AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017105-007AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017105-007AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017105-007AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017105-007AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017105-007AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017105-007AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017105-007AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017105-007AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017105-007AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017105-007AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017105-007AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017105-007AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017105-007AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017105-007AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017105-007AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017105-007AB1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMClinical Solutions Wholesale, LLC11b72861-64c9-4cdc-9289-c7fa9ea23bf62026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMSun Pharmaceutical Industries, Inc.499a6989-8912-44b7-b1eb-ee8f85ae378f2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC919cbd07-f587-4005-acff-26213dd1d1fb2026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC40074ed8-0799-e3e0-e063-6394a90ad2002025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMApotex Corp.6e07efe5-29b6-6d1e-661a-f696c4b17f432025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMANI Pharmaceuticals, Inc.a4b80e69-b7c7-471a-8ce8-4e992808c6692025-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMPD-Rx Pharmaceuticals, Inc.7b59a3ab-3dff-4458-a63a-ef0d9e0d996d2025-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2d592a27-f4cf-008a-e063-6394a90a26292025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2ccaf945-0369-3129-e063-6394a90a27402025-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMNORTHSTAR RX LLCfb5c9e98-02b2-4c36-b436-25b58fe3c7d52024-10-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC69451c35-dd9a-4690-8d5e-4dcfa88376202024-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLORAZEPATE DIPOTASSIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55292-304Tranxeneclorazepate dipotassiumRecordati Rare Diseases, Inc.NDACurrent
55292-304Tranxeneclorazepate dipotassiumRecordati Rare Diseases Inc.NDACurrent
55292-304Tranxeneclorazepate dipotassiumRECORDATI RARE DISEASES, NDACurrent
55292-304Tranxeneclorazepate dipotassiumRECORDATI RARE DISEASES, INC.NDACurrent
55292-304Tranxeneclorazepate dipotassiumRECORDATI RARE DISEASES, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73223SUPPL2023-01-17
73222SUPPL2023-01-17
73166SUPPL2023-01-17
66188SUPPL2021-02-11
66187SUPPL2021-02-11
66138SUPPL2021-02-09
46626SUPPL2016-12-30
46459SUPPL2016-12-22
46232SUPPL2016-12-20
13088SUPPL2011-07-21
552SUPPL2010-06-15
10969SUPPL2010-06-14
551SUPPL2009-04-29
10968SUPPL2009-04-28
40737SUPPL2007-07-09
20070SUPPL2007-07-09
40738SUPPL2006-10-25
550SUPPL2003-03-26
13087SUPPL2002-02-07
549SUPPL2002-02-07