← FDA Drug Approvals (Drugs@FDA)

FLUOROURACIL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE · Approved 2021-10-07

Drug application

FDA Application #

ANDA214845

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOROURACIL

Generic name

FLUOROURACIL

Active ingredients

FLUOROURACIL

Dosage form

CREAM

Route

TOPICAL

Marketing status

Prescription

Sponsor

ACCORD HLTHCARE

Manufacturer

Accord Healthcare Inc.

First approval

2021-10-07

Source

Authoritative

Drugs@FDA application overview

Machine

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