FDA.reportPublic FDA data

FLUOROURACIL - Food and Drug Administration

Set ID
62fb8671-1693-49d8-8aab-0c1bfdd6794e
Type
Indexing - product concept
Effective date
2015-10-05
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use FAVLYXA safely and effectively. See full prescribing information for FAVLYXA. FAVLYXA™ (fluorouracil) injection, for intravenous use Initial U.S. Approval: 1962Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd.2026-09-24
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: 1962Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-09-22
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: 1962Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-09-22
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: 1962Product nameBluePoint Laboratories | Gland Pharma Limited2026-09-21
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: 1962Product nameBluePoint Laboratories | Gland Pharma Limited2026-09-21
These highlights do not include all the information needed to use FAVLYXA safely and effectively. See full prescribing information for FAVLYXA. FAVLYXA™ (fluorouracil) injection, for intravenous use Initial U.S. Approval: 1962Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd.2026-07-23
These highlights do not include all the information needed to use FAVLYXA safely and effectively. See full prescribing information for FAVLYXA. FAVLYXA™ (fluorouracil) injection, for intravenous use Initial U.S. Approval: 1962Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd.2026-07-16
Fluorouracil Topical Solution USP, 2% and 5%Product nameSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-15
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: 1962Product nameFresenius Kabi USA, LLC2026-07-15
Fluorouracil Cream USP, 5%Product nameSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-14
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: 1962Product nameBluePoint Laboratories | Alembic Pharmaceuticals Limited2026-07-14
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: 1962Product nameBluePoint Laboratories | Alembic Pharmaceuticals Limited2026-07-14
Fluorouracil Topical Cream USP, 5%Product nameNORTHSTAR RX LLC | Taro Pharmaceutical Industries Ltd.2026-07-08
These highlights do not include all the information needed to use FAVLYXA safely and effectively. See full prescribing information for FAVLYXA. FAVLYXA™ (fluorouracil) injection, for intravenous use Initial U.S. Approval: 1962Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd.2026-07-08
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: 1962Product nameFresenius Kabi USA, LLC2026-06-10
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: 1962Product nameFresenius Kabi USA, LLC2026-06-09
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: 1962Product nameFresenius Kabi USA, LLC2026-06-08
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: 1962Product nameMeitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2026-04-08
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: 1962Product nameMeitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2026-04-08
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: 1962Product nameBluePoint Laboratories | Alembic Pharmaceuticals Limited2026-03-31
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: 1962Product nameBluePoint Laboratories | Alembic Pharmaceuticals Limited2026-03-31
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: 1962Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd.2026-03-30
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: 1962Product nameFresenius Kabi USA, LLC2026-03-24
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: 1962Product nameFresenius Kabi USA, LLC2026-03-19
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: 1962Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC | Sichuan Huiyu Pharmaceutical Co., Ltd.2026-03-05
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: 1962Product nameBluePoint Laboratories | Gland Pharma Limited2026-02-26
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: 1962Product nameBluePoint Laboratories | Gland Pharma Limited2026-02-26
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: 1962Product nameXiromed LLC | Gland Pharma Limited2026-02-19
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: 1962Product nameXiromed LLC | Gland Pharma Limited2026-02-19
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: 1962Product nameSagent Pharmaceuticals2026-02-09
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: 1962Product nameAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2026-02-09
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: 1962Product nameAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2026-02-09
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50Product namee.l.f cosmetics,Inc.2026-02-01
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: 1962Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-01-21
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: 1962Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-01-21
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: 1962Product nameEugia US LLC | EUGIA Pharma Specialities Limited2026-01-19
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: 1962Product nameEugia US LLC | EUGIA Pharma Specialities Limited2026-01-19
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: 1962Product nameMeitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2026-01-16
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: 1962Product nameBluePoint Laboratories | Alembic Pharmaceuticals Limited2026-01-12
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: 1962Product nameBluePoint Laboratories | Alembic Pharmaceuticals Limited2026-01-12
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: 1962Product nameMeitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2026-01-06
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: 1962Product nameEugia US LLC | EUGIA Pharma Specialities Limited2025-11-18
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: 1962Product nameEugia US LLC | EUGIA Pharma Specialities Limited2025-11-17
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: 1962Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2025-11-12
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: 1962Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2025-11-12
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: 1962Product nameGland Pharma Limited2025-11-10
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: 1962Product nameGland Pharma Limited2025-11-10
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: 1962Product nameProPharma Distribution2025-11-07
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: 1962Product nameSagent Pharmaceuticals2025-10-31
FLUOROURACIL TOPICAL SOLUTION Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USEProduct nameEncube Ethicals, Inc. | Encube Ethicals Private Limited2025-10-09
FLUOROURACIL CREAM, USP 5% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USEProduct nameEncube Ethicals, Inc. | Encube Ethicals Private Limited2025-09-09
Fluorouracil Cream, 0.5% FOR TOPICAL DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USEProduct nameDr. Reddy's Laboratories Inc. | Extrovis AG | Kavis Pharma LLC2025-07-11
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 Initial U.S. Approval: 1962Product nameFresenius Kabi USA, LLC2025-07-09
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 OnlyProduct nameFresenius Kabi USA, LLC2025-06-11
EFUDEX ® (fluorouracil) TOPICAL SOLUTIONS AND CREAM FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USEProduct nameBausch Health US, LLC | Bausch Health Companies Inc. | Kavis Pharma LLC2025-04-23
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: 1962Product nameFresenius Kabi USA, LLC2024-12-19
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: 1962Product nameFresenius Kabi USA, LLC2024-12-16
Fluorouracil Cream USP 5% TOPICAL CREAMProduct nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited2024-10-04
Fluorouracil Cream USP, 5%Product nameTaro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd.2024-04-26
Fluorouracil Cream, USP 5%Product nameDr. Reddy's Labratories Inc.2024-04-01
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: 1962Product nameGland Pharma Limited2024-02-26
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: 1962Product nameGland Pharma Limited2024-02-26
FLUOROURACIL TOPICAL SOLUTION Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USEProduct nameEncube Ethicals Private Limited2023-12-01
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: 1962Product nameAlembic Pharmaceuticals Limited2023-11-16
Fluorouracil Cream USP, 5%Product nameNuCare Pharmaceuticals,Inc.2023-08-24
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: 1962Product nameAlembic Pharmaceuticals Limited2023-05-10
Fluorouracil Cream USP 5% TOPICAL CREAMProduct nameNuCare Pharmaceuticals,Inc.2023-03-20
Fluorouracil Topical Solution USP, 2% and 5%Product nameTaro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd.2022-09-29
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: 1962Product nameHILL DERMACEUTICALS, INC.2022-09-06
Fluorouracil Topical Cream USP, 5%Product nameNORTHSTAR RX LLC2021-12-10
Fluorouracil Cream, USP 5%Product nameMayne Pharma Inc. | Rockledge Pharmaceutical Manufacturing2021-11-04
Mylan Pharmaceuticals Inc. human prescription drug labelProduct nameMylan Pharmaceuticals Inc.2021-06-30
Fluorouracil Topical Cream USP, 5%Product nameA-S Medication Solutions2021-06-16
FluorouracilProduct nameRebel Distributors Corp2012-04-04
Fluorouracil Topical Cream USP, 5%Product nameTaro Pharmaceutical Industries Ltd.2010-08-18
Physicians Total Care, Inc. human prescription drug labelProduct namePhysicians Total Care, Inc.2009-09-22