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Last Updated: August 3, 2020

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Suppliers and packages for generic ingredient: FLUOROURACIL

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FLUOROURACIL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985 NDA Bausch Health Americas, Inc. 0187-5200-30 1 TUBE in 1 CARTON (0187-5200-30) > 30 g in 1 TUBE
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985 NDA AUTHORIZED GENERIC Spear Dermatology Products Inc 66530-258-30 30 g in 1 TUBE (66530-258-30)
Bausch EFUDEX fluorouracil CREAM;TOPICAL 016831 NDA Bausch Health US LLC 0187-3204-47 1 TUBE in 1 CARTON (0187-3204-47) > 40 g in 1 TUBE
Bausch EFUDEX fluorouracil CREAM;TOPICAL 016831 NDA Mylan Pharmaceuticals Inc. 0378-4791-06 1 TUBE in 1 CARTON (0378-4791-06) > 40 g in 1 TUBE
Almirall FLUOROPLEX fluorouracil CREAM;TOPICAL 016988 NDA Almirall, LLC 16110-812-30 1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE
Mayne Pharma FLUOROURACIL fluorouracil CREAM;TOPICAL 077524 ANDA Mayne Pharma Inc. 51862-362-40 1 TUBE in 1 CARTON (51862-362-40) > 40 g in 1 TUBE
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package

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