Application 211925

Type: ANDA
Sponsor: MICRO LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	TABLET;ORAL	EQ 12.5MG BASE;5MG	No	No
002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	TABLET;ORAL	EQ 25MG BASE;10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			2022-02-02
A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 25MG BASE;10MG	TABLET / ORAL			2022-02-02

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 2 of 2 · 68 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
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL		2022-02-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		2022-02-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211925-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211925-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211925-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211925-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211925-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211925-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211925-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211925-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211925-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211925-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211925-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211925-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211925-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211925-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211925-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211925-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211925-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211925-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211925-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211925-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211925-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211925-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211925-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211925-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211925-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211925-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211925-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211925-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211925-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211925-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211925-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211925-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211925-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211925-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211925-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211925-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211925-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211925-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211925-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211925-002	AB	1	`9b2671bbb829…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide and Amitriptyline Hydrochloride	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	66a756f2-ac77-451c-a19a-08896d73b15c	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlordiazepoxide and Amitriptyline Hydrochloride

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-302	Chlordiazepoxide and Amitriptyline Hydrochloride	Chlordiazepoxide and Amitriptyline Hydrochloride	Micro Labs Limited	ANDA	Current
42571-303	Chlordiazepoxide and Amitriptyline Hydrochloride	Chlordiazepoxide and Amitriptyline Hydrochloride	Micro Labs Limited	ANDA	Current