Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016831

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EFUDEX (FLUOROURACIL)
5%
Marketing Status: Prescription

Active Ingredient: FLUOROURACIL
Proprietary Name: EFUDEX
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N016831
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EFUDEX (FLUOROURACIL)
2%
Marketing Status: Prescription

Active Ingredient: FLUOROURACIL
Proprietary Name: EFUDEX
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N016831
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EFUDEX (FLUOROURACIL)
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: FLUOROURACIL
Proprietary Name: EFUDEX
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N016831
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information