Assyro AI

Orange Book product · Brand (NDA)

AVITA

TRETINOIN

Brand (NDA)NDA 020404TE ABRX MYLAN PHARMS INC

At a glance

Jan 14, 1997

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 14, 1997

    29 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TRETINOIN

Strength

0.025%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

NDA 020404

Product number

003

Marketing status

RX

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.