FDA.reportPublic FDA data

Application 012301

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIBRIUMCHLORDIAZEPOXIDE HYDROCHLORIDEINJECTABLE;INJECTION100MG/AMPNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012301-001LIBRIUMCHLORDIAZEPOXIDE HYDROCHLORIDE100MG/AMPINJECTABLE / INJECTIONApproved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N012301-001LIBRIUM100MG/AMPINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012301-001LIBRIUM100MG/AMPINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012301-001LIBRIUM100MG/AMPINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEREMEDYREPACK INC.9aba3135-00ff-47ba-b926-55eb16b361bf2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEREMEDYREPACK INC.43daab7a-3809-4b13-b015-4806912c3c4a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDECoupler LLC54d76424-7fab-c000-e063-6294a90af43e2026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEUnit Dose Solutions, Inc.53c278b6-d22d-79bd-e063-6294a90a82cd2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDECouper LLC511264f5-024b-350a-e063-6394a90a51e92026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDESafecor Health, LLC60abf20f-0c6c-43b9-8b55-f4957e2a655d2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEChartwell RX, LLCdd5f82b0-5a56-4728-941a-c8c2a0d51cc42025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEMylan Institutional Inc.68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a2025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3cbd7cee-c4d7-4c95-93d8-09428169b9372025-09-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEBryant Ranch Prepackf04714bc-4ce0-4693-9cd8-5789193254742025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e3ff8641-ae8a-4016-acb1-cb1b7890f5ed2025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a57a5046-f73b-10a9-e053-2a95a90ad72f2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e64d2d8-b12c-5639-e053-2a95a90aab802024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEClinical Solutions Wholesale, LLC3d4cab96-8a67-4d26-a9cc-b1a02fb6c1462024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEClinical Solutions Wholesale, LLC74c4320d-c90d-436b-97da-07496ba88aed2024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma, LLC2e198c16-a929-4028-8f96-25dd23f74b102023-02-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma LLC8255992f-3256-4558-bd0d-cfe350d95f252022-03-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORDIAZEPOXIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
317SUPPL2002-05-07