Assyro AI

Orange Book product · Brand (NDA)

TEGISON

ETRETINATE

Brand (NDA)NDA 019369DISCN ROCHE

At a glance

Sep 30, 1986

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 30, 1986

    40 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETRETINATE

Strength

25MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 019369

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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

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