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FLUOROMETHOLONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DIFGEN PHARMS · Approved 2026-02-12

Drug application

FDA Application #

ANDA218819

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOROMETHOLONE

Generic name

FLUOROMETHOLONE

Active ingredients

FLUOROMETHOLONE

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

DIFGEN PHARMS

Manufacturer

Sandoz Inc

First approval

2026-02-12

Source

Authoritative

Drugs@FDA application overview

Machine

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