| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd. | 20260408 | 11 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd. | 20260408 | 4 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | BluePoint Laboratories | Alembic Pharmaceuticals Limited | 20260331 | 5 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion. Initial U.S. Approval: 1962 | BluePoint Laboratories | Alembic Pharmaceuticals Limited | 20260331 | 5 |
| These highlights do not include all the information needed to use FAVLYXA safely and effectively. See full prescribing information for FAVLYXA. FAVLYXA TM (fluorouracil) injection, for intravenous use Initial U.S. Approval: 1962 | Avyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd. | 20260330 | 2 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package – Not for Direct Infusion Initial U.S. Approval: 1962 | Fresenius Kabi USA, LLC | 20260324 | 6 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Fresenius Kabi USA, LLC | 20260319 | 10 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FLUOROURACIL injection safely and effectively. See full prescribing information for FLUOROURACIL injection. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | BluePoint Laboratories | Gland Pharma Limited | 20260226 | 5 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | BluePoint Laboratories | Gland Pharma Limited | 20260226 | 5 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Xiromed LLC | Gland Pharma Limited | 20260219 | 7 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Xiromed LLC | Gland Pharma Limited | 20260219 | 4 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use only Initial U.S. Approval: 1962 | Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd | 20260209 | 6 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd | 20260209 | 5 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Eugia US LLC | EUGIA Pharma Specialities Limited | 20260119 | 5 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package – Not for Direct Infusion Initial U.S. Approval: 1962 | Eugia US LLC | EUGIA Pharma Specialities Limited | 20260119 | 3 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20251112 | 8 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion. Initial U.S. Approval: 1962 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20251112 | 6 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Gland Pharma Limited | 20251110 | 8 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Gland Pharma Limited | 20251110 | 7 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | ProPharma Distribution | 20251107 | 1 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Sagent Pharmaceuticals | 20251031 | 9 |
| FLUOROURACIL TOPICAL SOLUTION Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE | Encube Ethicals, Inc. | Encube Ethicals Private Limited | 20251009 | 4 |
| FLUOROURACIL CREAM, USP 5% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE | Encube Ethicals, Inc. | Encube Ethicals Private Limited | 20250909 | 3 |
| Fluorouracil Cream, 0.5% FOR TOPICAL DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE | Dr. Reddy's Laboratories Inc. | Extrovis AG | Kavis Pharma LLC | 20250711 | 1 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 | Fresenius Kabi USA, LLC | 20250709 | 5 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 Rx Only | Fresenius Kabi USA, LLC | 20250611 | 5 |
| EFUDEX ® (fluorouracil) TOPICAL SOLUTIONS AND CREAM FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE | Bausch Health US, LLC | Bausch Health Companies Inc. | Kavis Pharma LLC | 20250423 | 20 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package – Not for Direct Infusion Initial U.S. Approval: 1962 | Fresenius Kabi USA, LLC | 20241219 | 4 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | Fresenius Kabi USA, LLC | 20241216 | 5 |
| Fluorouracil Cream USP 5% TOPICAL CREAM | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 20241004 | 5 |
| Fluorouracil Cream USP, 5% | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd. | 20240426 | 10 |
| Fluorouracil Cream, USP 5% | Dr. Reddy's Labratories Inc. | 20240401 | 1 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion. Initial U.S. Approval: 1962 | Alembic Pharmaceuticals Limited | 20231116 | 1 |
| Fluorouracil Cream USP, 5% | NuCare Pharmaceuticals,Inc. | 20230824 | 1 |
| These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962 | Alembic Pharmaceuticals Limited | 20230510 | 1 |
| Fluorouracil Cream USP 5% TOPICAL CREAM | NuCare Pharmaceuticals,Inc. | 20230320 | 1 |
| Fluorouracil Topical Solution USP, 2% and 5% | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd. | 20220929 | 6 |
| These highlights do not include all the information needed to use TOLAK CREAM safely and effectively. See full prescribing information for TOLAK CREAM. TOLAK (fluorouracil) Cream, 4%, for topical use Initial U.S. Approval: 1962 | HILL DERMACEUTICALS, INC. | 20220906 | 6 |
| Fluorouracil Topical Cream USP, 5% | NORTHSTAR RX LLC | 20211210 | 1 |
| Fluorouracil Cream, USP 5% | Mayne Pharma Inc. | Rockledge Pharmaceutical Manufacturing | 20211104 | 3 |
| 744737c5-0d96-4214-82ab-6cff016b1ea0 | Mylan Pharmaceuticals Inc. | 20210630 | 11 |
| Fluorouracil Topical Cream USP, 5% | A-S Medication Solutions | 20210616 | 5 |
| Fluorouracil | Rebel Distributors Corp | 20120404 | 1 |
| Fluorouracil Topical Cream USP, 5% | Taro Pharmaceutical Industries Ltd. | 20100818 | 1 |
| bf851a7f-902d-4f1d-9d19-fd9cd5701fcd | Physicians Total Care, Inc. | 20090922 | 1 |