Assyro AI

Orange Book product · Generic (ANDA)

FLUOCINONIDE

FLUOCINONIDE

Generic (ANDA)ANDA 207680DISCN PAI HOLDINGS PHARM

At a glance

Sep 28, 2018

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 28, 2018

    7 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOCINONIDE

Strength

0.05%

Dosage form

OINTMENT

Route

TOPICAL

TE code

Not listed

Application

ANDA 207680

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUOCINONIDE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.