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Details for New Drug Application (NDA): 040334

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NDA 040334 describes FLUOROURACIL, which is a drug marketed by Bedford, Sagent Pharms, Spectrum Pharms, Abraxis Pharm, Spear Pharms Inc, Spear Pharms, Taro, Abic, Teva Pharms Usa, Smith And Nephew, Accord Hlthcare, Mylan Labs Ltd, Ebewe Pharma, Fresenius Kabi Usa, Marchar, and Sandoz, and is included in twenty-eight NDAs. It is available from twelve suppliers. Additional details are available on the FLUOROURACIL profile page.

The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

Summary for NDA: 040334

Teva Pharms Usa
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 040334

Suppliers and Packaging for NDA: 040334

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 040334 ANDA Teva Parenteral Medicines, Inc. 0703-3018 0703-3018-12 5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0703-3018-12) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0703-3018-11)
INJECTABLE;INJECTION 040334 ANDA Teva Parenteral Medicines, Inc. 0703-3019 0703-3019-12 5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0703-3019-12) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0703-3019-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/50ML (50MG/ML)
Approval Date:Feb 25, 2000TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML (50MG/ML)
Approval Date:Feb 25, 2000TE:APRLD:Yes

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