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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 090368


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NDA 090368 describes FLUOROURACIL, which is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Rising, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland Pharma Ltd, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Encube, and is included in thirty-eight NDAs. It is available from seventeen 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. Twenty suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 090368
Tradename:FLUOROURACIL
Applicant:Taro
Ingredient:fluorouracil
Patents:0
Pharmacology for NDA: 090368
Medical Subject Heading (MeSH) Categories for 090368
Suppliers and Packaging for NDA: 090368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil CREAM;TOPICAL 090368 ANDA NORTHSTAR RX LLC 16714-178 16714-178-01 1 TUBE in 1 CARTON (16714-178-01) / 40 g in 1 TUBE
FLUOROURACIL fluorouracil CREAM;TOPICAL 090368 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4118 51672-4118-2 1 TUBE in 1 CARTON (51672-4118-2) / 25 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Mar 5, 2010TE:ABRLD:No

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