Application 081222
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADRUCIL | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A081222-001 | ADRUCIL | FLUOROURACIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A081222-001 | ADRUCIL | 50MG/ML | INJECTABLE / INJECTION | 1991-06-28 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| FAVLYXA | FLUOROURACIL | Avyxa Pharma, LLC | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Sun Pharmaceutical Industries, Inc. | 1b2f6145-b338-42ed-88a7-f4da65c59164 | 2026-07-15 | Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | c612b05f-f37d-47fa-9c1e-b2d876dd7093 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | cdf07a8b-91ee-424f-8c04-34f53dfb82be | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Sun Pharmaceutical Industries, Inc. | acca0036-f19c-459b-9dfc-9592f1cd588d | 2026-07-14 | Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | NORTHSTAR RX LLC | 52ef5f41-2312-4b55-aa86-abd5bb28b9d3 | 2026-07-08 | Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | b4328ae3-f48f-40b1-9719-1c1aced7c734 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | a85ab26a-05ea-498f-8f34-564a925fa9d9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | 21af1777-87f7-4e40-9917-f1677e7ff1a5 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Meitheal Pharmaceuticals Inc. | de8a3fce-85a9-4a77-a3cd-e50179b93098 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Meitheal Pharmaceuticals Inc. | a0cd6301-c6e0-4b62-8683-39c99913db24 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | c45f5286-a52b-43e5-8a6f-d0312e7da0c8 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | 300304fa-4791-4455-962c-493ae467f504 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | 9c42eeff-ab0c-4820-94d7-e1a3df9fda74 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Xiromed LLC | 19735014-c6fb-0a05-c330-2e9389c71216 | 2026-02-19 | Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Xiromed LLC | f4b0cae1-a2fc-2991-d663-3b729503cd1c | 2026-02-19 | Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Accord Healthcare, Inc. | 8eff167f-203a-4a81-b2fc-d8773bc3555e | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| Fluorouracil | FLUOROURACIL | Accord Healthcare, Inc. | 66d451fe-2436-494c-80c5-4528c8e34369 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |
| fluorouracil | FLUOROURACIL | Sagent Pharmaceuticals | 37e35e8c-5d51-413b-a3a0-b72a18caaf65 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | FLUOROURACIL |