Assyro AI

Orange Book product · Brand (NDA)

DERMA-SMOOTHE/FS

FLUOCINOLONE ACETONIDE

Brand (NDA)NDA 019452TE ATRX HILL DERMAC
View FLUOCINOLONE ACETONIDE familyOpen on FDA Orange Book

At a glance

Nov 09, 2005

Approved

Brand (NDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 09, 2005

    20 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOCINOLONE ACETONIDE

Strength

0.01%

Dosage form

OIL

Route

TOPICAL

TE code

AT

Application

NDA 019452

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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.

Agent CTA Background

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