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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040798

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NDA 040798 describes FLUOROURACIL, which is a drug marketed by Mylan Pharms Inc, Spear Pharms, Taro, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marchar, Mylan Labs Ltd, Sagent Pharms, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Taro Pharm, and is included in thirty 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 040798
Tradename:FLUOROURACIL
Applicant:Accord Hlthcare
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040798
Medical Subject Heading (MeSH) Categories for 040798
Suppliers and Packaging for NDA: 040798
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040798 ANDA Accord Healthcare, Inc. 16729-276 16729-276-67 10 VIAL in 1 CARTON (16729-276-67) > 20 mL in 1 VIAL (16729-276-05)
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040798 ANDA Accord Healthcare, Inc. 16729-276 16729-276-68 10 VIAL in 1 CARTON (16729-276-68) > 10 mL in 1 VIAL (16729-276-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML (50MG/ML)
Approval Date:Apr 26, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/50ML (50MG/ML)
Approval Date:Apr 26, 2007TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Accenture
McKinsey
Cerilliant
Covington
Federal Trade Commission
UBS
Express Scripts
Harvard Business School

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