Application 075731

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	15MG	No	No
002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	7.5MG	No	No
003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	3.75MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075731-001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27
A075731-002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27
A075731-003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075731-001	AB
A075731-002	AB
A075731-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075731-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075731-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075731-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075731-001	AB	1	`8072bd15b7f6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Clinical Solutions Wholesale, LLC	11b72861-64c9-4cdc-9289-c7fa9ea23bf6	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Sun Pharmaceutical Industries, Inc.	499a6989-8912-44b7-b1eb-ee8f85ae378f	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731 ndc (product): 51672-4042 ndc (product): 51672-4044 ndc (product): 51672-4043
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	40074ed8-0799-e3e0-e063-6394a90ad200	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	PD-Rx Pharmaceuticals, Inc.	7b59a3ab-3dff-4458-a63a-ef0d9e0d996d	2025-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731 ndc (product): 72789-256
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	2ccaf945-0369-3129-e063-6394a90a2740	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	NORTHSTAR RX LLC	fb5c9e98-02b2-4c36-b436-25b58fe3c7d5	2024-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731 ndc (product): 72603-114 ndc (product): 72603-113 ndc (product): 72603-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-433	Clorazepate Dipotassium	Clorazepate Dipotassium	Rebel Distributors Corp	ANDA	Current
21695-434	Clorazepate Dipotassium	Clorazepate Dipotassium	Rebel Distributors Corp	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-893	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51672-4042	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4042	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4042	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4043	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4043	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4043	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4044	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4044	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4044	Clorazepate Dipotassium	Clorazepate Dipotassium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
63629-3646	Clorazepate Dipotassium	Clorazepate Dipotassium	Bryant Ranch Prepack	ANDA	Current
63629-3859	Clorazepate Dipotassium	Clorazepate Dipotassium	Bryant Ranch Prepack	ANDA	Current
72603-112	Clorazepate Dipotassium	Clorazepate Dipotassium	NORTHSTAR RX LLC	ANDA	Current
72603-113	Clorazepate Dipotassium	Clorazepate Dipotassium	NORTHSTAR RX LLC	ANDA	Current
72603-114	Clorazepate Dipotassium	Clorazepate Dipotassium	NORTHSTAR RX LLC	ANDA	Current
72789-256	Clorazepate Dipotassium	Clorazepate Dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31001	ORIG	2000-04-27