← FDA Drug Approvals (Drugs@FDA)

FLUOROURACIL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2023-11-02

Drug application

FDA Application #

ANDA215612

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOROURACIL

Generic name

FLUOROURACIL

Active ingredients

FLUOROURACIL

Dosage form

SOLUTION

Route

TOPICAL

Marketing status

Prescription

Sponsor

ENCUBE

Manufacturer

Encube Ethicals, Inc.

First approval

2023-11-02

Source

Authoritative

Drugs@FDA application overview

Machine

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