Application 213730

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	3.75MG	No	No
002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	7.5MG	No	No
003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	15MG	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
A213730-001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16
A213730-002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16
A213730-003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213730-001	AB
A213730-002	AB
A213730-003	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 2 · 80 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	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213730-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2022-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213730-003	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2022-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213730-001	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2022-06-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A213730-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213730-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213730-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213730-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213730-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213730-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213730-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213730-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213730-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213730-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213730-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213730-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213730-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213730-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213730-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213730-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213730-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213730-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213730-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213730-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213730-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213730-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213730-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213730-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213730-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213730-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213730-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213730-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213730-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213730-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213730-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213730-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213730-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213730-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213730-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213730-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213730-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213730-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213730-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213730-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	ANI Pharmaceuticals, Inc.	a4b80e69-b7c7-471a-8ce8-4e992808c669	2025-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213730 application number: ANDA213730 ndc (product): 70954-158 ndc (product): 70954-159 ndc (product): 70954-157
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	2d592a27-f4cf-008a-e063-6394a90a2629	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213730 application number: ANDA213730

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70954-157	Clorazepate Dipotassium	Clorazepate Dipotassium	ANI Pharmaceuticals, Inc.	ANDA	Current
70954-158	Clorazepate Dipotassium	Clorazepate Dipotassium	ANI Pharmaceuticals, Inc.	ANDA	Current
70954-158	Clorazepate Dipotassium	Clorazepate Dipotassium	Novitium Pharma LLC	ANDA	Current
70954-158	Clorazepate Dipotassium	Clorazepate Dipotassium	Novitium Pharma LLC	ANDA	Current
70954-159	Clorazepate Dipotassium	Clorazepate Dipotassium	ANI Pharmaceuticals, Inc.	ANDA	Current
70954-159	Clorazepate Dipotassium	Clorazepate Dipotassium	Novitium Pharma LLC	ANDA	Current
70954-159	Clorazepate Dipotassium	Clorazepate Dipotassium	Novitium Pharma LLC	ANDA	Current