Assyro AI

Orange Book product · Generic (ANDA)

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

Generic (ANDA)ANDA 212762TE ATRX QUAGEN

At a glance

Apr 02, 2021

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 02, 2021

    5 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOCINOLONE ACETONIDE

Strength

0.01%

Dosage form

OIL/DROPS

Route

OTIC

TE code

AT

Application

ANDA 212762

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUOCINOLONE ACETONIDE

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.