FDA.reportPublic FDA data

Application 016087

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALIUMDIAZEPAMINJECTABLE;INJECTION5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016087-001VALIUMDIAZEPAM5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N016087-001VALIUM5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016087-001VALIUM5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016087-001VALIUM5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016087-001VALIUM5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…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 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMCardinal Health 107, LLCba953b22-f0cd-4be5-9e0e-178bded887272026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMCivica, Inc.cf7bd9ba-5030-479a-8448-3a99395b0d0c2026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMREMEDYREPACK INC.b4a045e4-d6ce-475d-abe4-590941bd38152026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMREMEDYREPACK INC.20e08b97-bb89-4129-a228-8ad9cf35a1d32026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMHikma Pharmaceuticals USA Inc.f466f8a3-f31c-44f4-b0e8-444464f20f662026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMREMEDYREPACK INC.5ebef149-1858-4199-aaed-7b9341fae63d2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMUnit Dose Solutions, Inc.547c2ad4-113c-7771-e063-6394a90a20732026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
ValtocoDIAZEPAMNeurelis, Inc1a8bcc90-68fa-474d-832c-0df01e825f392026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMNavinta LLCb5b17a28-2cab-4c0d-8f9d-7b224e4d09892026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMHospira, Inc.7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMCoupler LLC5111654f-a026-71b2-e063-6294a90ab49b2026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMCoupler LLC5114ae6e-8cae-e96f-e063-6294a90a9e602026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMBaxter Healthcare Corporationa0813073-d0b0-4fd7-b307-56f69c910c822026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMZydus Pharmaceuticals USA Inc.652714c7-25c4-4d05-979d-8eee3b6f2f4d2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMDr. Reddy's Laboratories Inc2a633cef-6dfc-4186-b595-174db2d8330e2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMDr. Reddy's Laboratories Inc9a860a4e-d670-d050-499d-eb1fd6b161762026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.6dcbb5e9-1e8f-4069-9244-adb46356714d2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.7646785b-dabc-482d-bf42-06177f00aca22026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DIAZEPAMDIAZEPAMHenry Schein, Inc.52fc91f4-992f-47cb-a7d2-b26d745774812026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMREMEDYREPACK INC.d7a4b3c7-7021-4764-8c21-49e4bc6f60582026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12971SUPPL2002-02-07
12970SUPPL2002-02-07