Application 215453

Type: ANDA
Sponsor: COREPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	CAPSULE;ORAL	5MG;2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB		2022-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215453-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215453-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2022-07-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215453-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215453-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215453-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215453-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215453-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215453-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215453-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215453-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215453-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215453-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215453-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215453-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215453-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215453-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215453-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215453-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215453-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215453-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215453-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215453-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215453-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215453-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215453-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215453-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215453-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215453-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215453-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215453-001	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	d4ed59f7-7624-480f-b151-2d4e9b6b7013	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Chartwell RX, LLC	a0d735c2-e7a9-4843-a78d-203c9598682d	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE	Misemer Pharmaceuticals, Inc	a42fc981-77bc-4c9e-a79d-b821bffb65b4	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Winder Laboratories LLC	87d1a147-d3c3-4097-aac0-4b19c49eabe3	2025-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Ascend Laboratories, LLC	19fdde81-e0f2-4269-bd57-252a759b7593	2025-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
chlordiazepoxide hydrochloride and clidinium bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Amneal Pharmaceuticals NY LLC	b4ef805f-9fc3-47f7-b1f7-328c54970e5d	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: chlordiazepoxide hydrochloride and clidinium bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	American Health Packaging	0fb80410-4689-4b8e-bfbb-19a62c9fe888	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	01d1e922-f3a8-4af3-99ec-94b927187373	2024-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	160c6524-314f-404a-ac04-0f3bfae2fde3	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide hydrochloride and clidinium bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Alembic Pharmaceuticals Limited	398931c6-4954-4bbc-8b63-ea382e5864fc	2023-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide hydrochloride and clidinium bromide
Chlordiazepoxide hydrochloride and clidinium bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Alembic Pharmaceuticals Inc.	e37c96f1-0738-49c7-ad46-c8ae0a998cf7	2023-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide hydrochloride and clidinium bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Aurobindo Pharma Limited	0fda7521-a452-4bac-953d-7d464d75ca22	2023-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	68d8dca6-697d-401e-acaf-01bfe4c4da17	2023-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	c3223f35-1baf-46bf-9eb3-55455f672d85	2023-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Sunrise Pharmaceutical, Inc.	3cce1912-e7c8-4f30-bd76-dfa4b9d65bac	2022-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide Hydrochloride and Clidinium Bromide