FDA.reportPublic FDA data

Application 020073

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROMAZICONFLUMAZENILINJECTABLE;INJECTION1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ROMAZICONFLUMAZENILINJECTABLE;INJECTION0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020073-001ROMAZICONFLUMAZENIL1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20
N020073-002ROMAZICONFLUMAZENIL0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N020073-001ROMAZICON1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20e64feba35796…
2022-09-29 23:25 UTC2022-09N020073-002ROMAZICON0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020073-001ROMAZICON1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020073-002ROMAZICON0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020073-001ROMAZICON1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020073-002ROMAZICON0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-12-20a50c72e98297…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUMAZENILFLUMAZENILHF Acquisition Co LLC, DBA HealthFirst56452ba8-521d-1f84-e063-6294a90af6fc2026-07-10Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FLUMAZENILFLUMAZENILHF Acquisition Co LLC, DBA HealthFirstc5da455f-3213-ab11-e053-2995a90a54ee2026-07-01Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FLUMAZENILFLUMAZENILHF Acquisition Co. LLC, DBA HealthFirst74d007e9-9604-0941-e053-2a91aa0a29c42026-06-19Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC53d9144a-b7ee-b52a-e063-6294a90a09c52026-06-09Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILProPharma Distribution3eefb01b-3d6a-a3eb-e063-6394a90a48292025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILProPharma Distribution3f7a30b5-2728-0c82-e063-6394a90a92dd2025-09-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILFresenius Kabi USA, LLCa72d9fc1-121c-455d-93a9-002378c9968f2025-03-27Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FLUMAZENILFLUMAZENILHenry Schein, Inc.1855bb03-392f-4a0d-8361-24fc2a0e635e2025-02-14Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FLUMAZENILFLUMAZENILHenry Schein, Inc.3ea41cbe-bc07-4c95-8bb2-7dfc2e96a8742025-02-14Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC28f31b54-ff30-fd0d-e063-6394a90afc182024-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILHikma Pharmaceuticals USA Inc.436f5616-9626-4b6a-9deb-2986444179d02024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILA-S Medication Solutions2190e8d0-d7ca-4f53-b243-0d2c31979aa82024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILHikma Pharmaceuticals USA Inc.442ed32b-b508-40cc-9915-ff05674566da2024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FLUMAZENILFLUMAZENILHF Acquisition Co. LLC, DBA Health First744ef484-ef46-8d62-e053-2a91aa0a0c052024-01-29Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC6673efde-057a-a889-e053-2a91aa0a517b2023-05-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC9f68c61a-c207-cdbe-e053-2a95a90af5a02023-05-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC6671d89f-cc82-c03c-e053-2a91aa0aa5fa2022-10-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL
FlumazenilFLUMAZENILBaxter Healthcare Corporation8175c1eb-80af-48f1-813c-c8f0e736d8942020-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUMAZENIL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12179SUPPL2007-10-10
1985SUPPL2007-10-10
1984SUPPL2004-03-10
34235SUPPL2004-03-05