Assyro AI

Orange Book product · Brand (NDA)

EVAMIST

ESTRADIOL

Brand (NDA)NDA 022014RX PADAGIS US

At a glance

Jul 27, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 27, 2007

    19 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTRADIOL

Strength

1.53MG/SPRAY

Dosage form

SPRAY

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 022014

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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.