Assyro AI

Orange Book product · Brand (NDA)

TESTODERM TTS

TESTOSTERONE

Brand (NDA)NDA 020791DISCN ALZA

At a glance

Dec 18, 1997

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 18, 1997

    28 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TESTOSTERONE

Strength

5MG/24HR

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 020791

Product number

001

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.