Assyro AI

Orange Book product · Generic (ANDA)

ESTRADIOL

ESTRADIOL

Generic (ANDA)ANDA 206685TE AB3RX MYLAN TECHNOLOGIES

At a glance

Aug 15, 2018

Approved

Generic (ANDA)

Application

AB3

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 15, 2018

    8 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTRADIOL

Strength

0.025MG/24HR

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

AB3

Application

ANDA 206685

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESTRADIOL

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.