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EFUDEX

NDA · New Drug Application · Sponsor: EXTROVIS · Approved 1970-07-29

Drug application

FDA Application #

NDA016831

Application type

New Drug Application

Brand name

EFUDEX

Generic name

FLUOROURACIL

Active ingredients

FLUOROURACIL

Dosage form

CREAM

Route

TOPICAL

Marketing status

Prescription

Sponsor

EXTROVIS

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

1970-07-29

Source

Authoritative

Drugs@FDA application overview

Machine

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