Application 214065

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB		2021-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214065-001	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	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`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	A214065-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214065-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214065-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214065-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214065-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214065-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214065-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214065-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214065-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214065-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214065-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214065-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214065-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214065-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214065-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214065-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214065-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214065-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214065-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214065-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214065-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214065-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214065-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214065-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214065-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214065-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214065-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214065-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214065-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214065-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214065-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214065-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214065-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214065-001	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 · 3 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	Ascend Laboratories, LLC	19fdde81-e0f2-4269-bd57-252a759b7593	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214065 application number: ANDA214065 ndc (product): 67877-731
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	Exact identifier application applno (ANDA): 214065 application number: ANDA214065 ndc (product): 60687-639
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	Exact identifier application applno (ANDA): 214065 application number: ANDA214065 ndc (product): 63629-8859

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-639	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	American Health Packaging	ANDA	Current
60687-639	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	American Health Packaging	ANDA	Current
63629-8859	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bryant Ranch Prepack	ANDA	Current
63629-8859	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bryant Ranch Prepack	ANDA	Current
63629-8859	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bryant Ranch Prepack	ANDA	Current
63629-8859	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bryant Ranch Prepack	ANDA	Current
67877-731	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Ascend Laboratories, LLC	ANDA	Current
67877-731	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65887	ORIG	2021-01-12