Assyro AI

Orange Book product · Generic (ANDA)

ESTRADIOL

ESTRADIOL

Generic (ANDA)ANDA 218214TE ABRX ENCUBE

At a glance

May 11, 2026

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 11, 2026

    1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTRADIOL

Strength

0.06% (1.25GM/ACTIVATION)

Dosage form

GEL, METERED

Route

TRANSDERMAL

TE code

AB

Application

ANDA 218214

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.