Assyro AI

Orange Book product · Brand (NDA)

FEMRING

ESTRADIOL ACETATE

Brand (NDA)NDA 021367RX MILLICENT MFG PR

At a glance

Mar 20, 2003

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 20, 2003

    23 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTRADIOL ACETATE

Strength

EQ 0.05MG BASE/24HR

Dosage form

INSERT, EXTENDED RELEASE

Route

VAGINAL

TE code

Not listed

Application

NDA 021367

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.