Application 017105

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANXENE	CLORAZEPATE DIPOTASSIUM	CAPSULE;ORAL	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	TRANXENE	CLORAZEPATE DIPOTASSIUM	CAPSULE;ORAL	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	TRANXENE	CLORAZEPATE DIPOTASSIUM	CAPSULE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	TRANXENE SD	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	TRANXENE SD	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
006	TRANXENE	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	TRANXENE	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	7.5MG	Yes	No
008	TRANXENE	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N017105-001	TRANXENE	CLORAZEPATE DIPOTASSIUM	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982
N017105-002	TRANXENE	CLORAZEPATE DIPOTASSIUM	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982
N017105-003	TRANXENE	CLORAZEPATE DIPOTASSIUM	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982
N017105-004	TRANXENE SD	CLORAZEPATE DIPOTASSIUM	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N017105-005	TRANXENE SD	CLORAZEPATE DIPOTASSIUM	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N017105-006	TRANXENE	CLORAZEPATE DIPOTASSIUM	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N017105-007	TRANXENE	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017105-008	TRANXENE	CLORAZEPATE DIPOTASSIUM	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

Therapeutic equivalence codes#

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

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

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 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017105-001	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-002	TRANXENE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-003	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-004	TRANXENE SD	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-005	TRANXENE SD	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-006	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-007	TRANXENE	7.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017105-008	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017105-001	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-002	TRANXENE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-003	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-004	TRANXENE SD	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-005	TRANXENE SD	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-006	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-007	TRANXENE	7.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017105-008	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017105-001	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-002	TRANXENE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-003	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-004	TRANXENE SD	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-005	TRANXENE SD	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-006	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-007	TRANXENE	7.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017105-008	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-001	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-002	TRANXENE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-003	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-004	TRANXENE SD	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-005	TRANXENE SD	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-006	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-007	TRANXENE	7.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017105-008	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017105-001	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-002	TRANXENE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-003	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-004	TRANXENE SD	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-005	TRANXENE SD	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-006	TRANXENE	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-007	TRANXENE	7.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017105-008	TRANXENE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N017105-007	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017105-007	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017105-007	AB	1	`a50c72e98297…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Apotex Corp.	6e07efe5-29b6-6d1e-661a-f696c4b17f43	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Clinical Solutions Wholesale, LLC	11b72861-64c9-4cdc-9289-c7fa9ea23bf6	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Sun Pharmaceutical Industries, Inc.	499a6989-8912-44b7-b1eb-ee8f85ae378f	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma LLC	919cbd07-f587-4005-acff-26213dd1d1fb	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	40074ed8-0799-e3e0-e063-6394a90ad200	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	ANI Pharmaceuticals, Inc.	a4b80e69-b7c7-471a-8ce8-4e992808c669	2025-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	2d592a27-f4cf-008a-e063-6394a90a2629	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	2ccaf945-0369-3129-e063-6394a90a2740	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	NORTHSTAR RX LLC	fb5c9e98-02b2-4c36-b436-25b58fe3c7d5	2024-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma LLC	69451c35-dd9a-4690-8d5e-4dcfa8837620	2024-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLORAZEPATE DIPOTASSIUM

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-304	Tranxene	clorazepate dipotassium	Recordati Rare Diseases, Inc.	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	Recordati Rare Diseases Inc.	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	RECORDATI RARE DISEASES,	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	RECORDATI RARE DISEASES, INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73223	SUPPL	2023-01-17
73222	SUPPL	2023-01-17
73166	SUPPL	2023-01-17
66188	SUPPL	2021-02-11
66187	SUPPL	2021-02-11
66138	SUPPL	2021-02-09
46626	SUPPL	2016-12-30
46459	SUPPL	2016-12-22
46232	SUPPL	2016-12-20
13088	SUPPL	2011-07-21
552	SUPPL	2010-06-15
10969	SUPPL	2010-06-14
551	SUPPL	2009-04-29
10968	SUPPL	2009-04-28
40737	SUPPL	2007-07-09
20070	SUPPL	2007-07-09
40738	SUPPL	2006-10-25
550	SUPPL	2003-03-26
13087	SUPPL	2002-02-07
549	SUPPL	2002-02-07