Assyro AI

Orange Book product · Generic (ANDA)

FLUOCINONIDE

FLUOCINONIDE

Generic (ANDA)ANDA 210554TE AB1RX AMNEAL

At a glance

Aug 21, 2018

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 21, 2018

    7 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOCINONIDE

Strength

0.05%

Dosage form

CREAM

Route

TOPICAL

TE code

AB1

Application

ANDA 210554

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.