Application 012750

Type: NDA
Sponsor: VALEANT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIBRAX	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	CAPSULE;ORAL	5MG;2.5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N012750-001	LIBRAX	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N012750-001	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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N012750-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N012750-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012750-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012750-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012750-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012750-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012750-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012750-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012750-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012750-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012750-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012750-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012750-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012750-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012750-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012750-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012750-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012750-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012750-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012750-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N012750-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012750-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012750-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012750-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012750-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012750-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012750-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012750-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012750-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012750-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012750-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012750-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012750-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012750-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012750-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012750-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012750-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012750-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012750-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012750-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Librax	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bausch Health US, LLC	f99ebf66-f207-4a97-9666-4da1d72b061c	2023-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 012750 application number: NDA012750 ndc (product): 0187-4100

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bausch Health US LLC	NDA	Current
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bausch Health US LLC	NDA	Current
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bausch Health US LLC	NDA	Current
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bausch Health Americas, Inc.	NDA	Current
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Valeant Pharmaceuticals International	NDA	Current
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bausch Health US LLC	NDA	Current
0187-4100	Librax	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bausch Health US LLC	NDA	Current
42494-409	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-409	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-409	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
50090-1528	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
63629-2146	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2146	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68151-2500	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
69189-0489	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	Avera McKennan Hospital	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73215	SUPPL	2023-01-17
73214	SUPPL	2023-01-17
73163	SUPPL	2023-01-17
66162	SUPPL	2021-02-09
66161	SUPPL	2021-02-09
66136	SUPPL	2021-02-09
46901	SUPPL	2017-01-19
46900	SUPPL	2017-01-19
46860	SUPPL	2017-01-13
46456	SUPPL	2016-12-22