Application 020073
- Type
- NDA
- Sponsor
- HOFFMANN LA ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROMAZICON | FLUMAZENIL | INJECTABLE;INJECTION | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ROMAZICON | FLUMAZENIL | INJECTABLE;INJECTION | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020073-001 | ROMAZICON | FLUMAZENIL | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | |
| N020073-002 | ROMAZICON | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) | INJECTABLE / INJECTION | RLD | 1991-12-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) | INJECTABLE / INJECTION | RLD | 1991-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) | INJECTABLE / INJECTION | RLD | 1991-12-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) | INJECTABLE / INJECTION | RLD | 1991-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020073-001 | ROMAZICON | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020073-002 | ROMAZICON | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1991-12-20 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FLUMAZENIL | FLUMAZENIL | HF Acquisition Co LLC, DBA HealthFirst | 56452ba8-521d-1f84-e063-6294a90af6fc | 2026-07-10 | Warnings, Adverse reactions | FLUMAZENIL |
| FLUMAZENIL | FLUMAZENIL | HF Acquisition Co LLC, DBA HealthFirst | c5da455f-3213-ab11-e053-2995a90a54ee | 2026-07-01 | Warnings, Adverse reactions | FLUMAZENIL |
| FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA HealthFirst | 74d007e9-9604-0941-e053-2a91aa0a29c4 | 2026-06-19 | Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Medical Purchasing Solutions, LLC | 53d9144a-b7ee-b52a-e063-6294a90a09c5 | 2026-06-09 | Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | ProPharma Distribution | 3eefb01b-3d6a-a3eb-e063-6394a90a4829 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | ProPharma Distribution | 3f7a30b5-2728-0c82-e063-6394a90a92dd | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Fresenius Kabi USA, LLC | a72d9fc1-121c-455d-93a9-002378c9968f | 2025-03-27 | Warnings, Adverse reactions | FLUMAZENIL |
| FLUMAZENIL | FLUMAZENIL | Henry Schein, Inc. | 1855bb03-392f-4a0d-8361-24fc2a0e635e | 2025-02-14 | Warnings, Adverse reactions | FLUMAZENIL |
| FLUMAZENIL | FLUMAZENIL | Henry Schein, Inc. | 3ea41cbe-bc07-4c95-8bb2-7dfc2e96a874 | 2025-02-14 | Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Medical Purchasing Solutions, LLC | 28f31b54-ff30-fd0d-e063-6394a90afc18 | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Hikma Pharmaceuticals USA Inc. | 436f5616-9626-4b6a-9deb-2986444179d0 | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | A-S Medication Solutions | 2190e8d0-d7ca-4f53-b243-0d2c31979aa8 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Hikma Pharmaceuticals USA Inc. | 442ed32b-b508-40cc-9915-ff05674566da | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA Health First | 744ef484-ef46-8d62-e053-2a91aa0a0c05 | 2024-01-29 | Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Medical Purchasing Solutions, LLC | 6673efde-057a-a889-e053-2a91aa0a517b | 2023-05-31 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Medical Purchasing Solutions, LLC | 9f68c61a-c207-cdbe-e053-2a95a90af5a0 | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Medical Purchasing Solutions, LLC | 6671d89f-cc82-c03c-e053-2a91aa0aa5fa | 2022-10-13 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
| Flumazenil | FLUMAZENIL | Baxter Healthcare Corporation | 8175c1eb-80af-48f1-813c-c8f0e736d894 | 2020-01-03 | Boxed warning, Warnings, Adverse reactions | FLUMAZENIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.