Application 083116

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	CAPSULE;ORAL	10MG	No	No

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
A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RLD, 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
A083116-001	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	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A083116-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A083116-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083116-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083116-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083116-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083116-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083116-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083116-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083116-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083116-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083116-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083116-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083116-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083116-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083116-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083116-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083116-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083116-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083116-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083116-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083116-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083116-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083116-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083116-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083116-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083116-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083116-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083116-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083116-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083116-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083116-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083116-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083116-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083116-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083116-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083116-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083116-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083116-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083116-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083116-001	AB	1	`3a93d1ddd44b…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	REMEDYREPACK INC.	9aba3135-00ff-47ba-b926-55eb16b361bf	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116 ndc (product): 70518-1752
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Coupler LLC	54d76424-7fab-c000-e063-6294a90af43e	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Safecor Health, LLC	60abf20f-0c6c-43b9-8b55-f4957e2a655d	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Mylan Institutional Inc.	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116 ndc (product): 51079-375
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e3ff8641-ae8a-4016-acb1-cb1b7890f5ed	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116 ndc (product): 0555-0033
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	74c4320d-c90d-436b-97da-07496ba88aed	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116 ndc (product): 58118-1033

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51079-375	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-375	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-375	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-375	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-375	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Mylan Institutional Inc.	ANDA	Current
55289-061	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
58118-1033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-1033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-1033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-1033	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Clinical Solutions Wholesale, LLC	ANDA	Current
63629-4669	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4669	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67046-909	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
70518-1752	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1752	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1752	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1752	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1752	Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	REMEDYREPACK INC.	ANDA	Current