TOLAK

Product NDC

64370-421

11-digit product format

643700421

Labeler code

64370

Product ID

64370-421_96366719-4060-7b9d-e053-2995a90ad7b9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

FLUOROURACIL

Dosage form

CREAM

Route

TOPICAL

Labeler

Pierre Fabre Pharmaceuticals, Inc.

Application

NDA022259

Marketing category

NDA

Marketing start

2017-03-15

Marketing end

2020-12-31

Substance

FLUOROURACIL

Active strength

40 mg/g

Pharmacologic classes

Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record