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Orange Book product · Brand (NDA)

FML

FLUOROMETHOLONE

Brand (NDA)NDA 017760DISCN ALLERGAN
View FLUOROMETHOLONE familyOpen on FDA Orange Book

At a glance

Sep 04, 1985

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 04, 1985

    41 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOROMETHOLONE

Strength

0.1%

Dosage form

OINTMENT

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 017760

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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