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FDA Approval

Fluoroplex

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Almirall, LLC
DUNS: 605425912
Effective Date
March 14, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil(10 mg in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fluoroplex

Product Details

NDC Product Code
16110-812
Application Number
NDA016988
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
August 15, 2016
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
Code: U3P01618RTClass: ACTIBQuantity: 10 mg in 1 g
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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