Application 012209
- Type
- NDA
- Sponsor
- SPECTRUM PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | FLUOROURACIL | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012209-001 | FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012209-002 | FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 |
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 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2016-07-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE / INJECTION | RLD | 2016-07-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE / INJECTION | RLD | 2016-07-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N012209-001 | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012209-002 | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE / INJECTION | RLD | 2016-07-29 | 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 |
|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | Eugia US LLC | 199ef964-8a9b-403e-a2ae-759280b3d1d1 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Gland Pharma Limited | 572b710e-8e2b-46eb-bd80-648ad769d34d | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Gland Pharma Limited | ea3497db-23b9-4ace-9a6f-b54853d04a82 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | ProPharma Distribution | 43057fcd-1f87-cc1a-e063-6294a90a8d24 | 2025-11-07 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Encube Ethicals, Inc. | 2c631ce7-ea15-4b51-b5bc-4962e3c315cd | 2025-10-09 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| FLUOROURACIL | FLUOROURACIL | Encube Ethicals, Inc. | 30294dd2-40fb-420d-b838-376343308895 | 2025-09-09 | Warnings, Adverse reactions | FLUOROURACIL FLUOROURACIL |
| FLUOROURACIL | FLUOROURACIL CREAM, 0.5% | Dr. Reddy's Laboratories Inc. | 37dcfb83-0e7d-d23d-9cd5-afa5bdc30628 | 2025-07-11 | Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | fdf2a165-2ca4-48be-89c1-570e6010b47c | 2025-06-11 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| Efudex | FLUOROURACIL | Bausch Health US, LLC | 35de1c1c-bef5-46c5-b6f8-ea032147411c | 2025-04-23 | FLUOROURACIL | |
| Fluorouracil | FLUOROURACIL | Accord Healthcare Inc. | 667d4059-de90-4d3f-86c2-c2573def2ecb | 2024-10-04 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| FLUOROURACIL | FLUOROURACIL | Dr. Reddy's Labratories Inc. | e137c766-1f7f-0251-90b9-450c3d4d78b9 | 2024-04-01 | Warnings, Adverse reactions | FLUOROURACIL FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Alembic Pharmaceuticals Limited | b6b0d9e2-c6f0-4523-a33b-b958d32d3a28 | 2023-11-16 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Alembic Pharmaceuticals Limited | d10f12a2-7b38-4351-93df-1e8444d2a9e4 | 2023-05-10 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
| TOLAK | FLUOROURACIL | HILL DERMACEUTICALS, INC. | 59de2709-00b8-4f0a-867c-f0dfeb947192 | 2022-09-06 | Warnings, Adverse reactions | FLUOROURACIL |
| FLUOROURACIL | FLUOROURACIL | Mayne Pharma Inc. | 06475bd8-66d9-4f88-90e4-b367480dab39 | 2021-11-04 | Warnings, Adverse reactions | FLUOROURACIL FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Mylan Pharmaceuticals Inc. | 744737c5-0d96-4214-82ab-6cff016b1ea0 | 2021-06-30 | Warnings, Adverse reactions | Fluorouracil FLUOROURACIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.