Assyro AI

Orange Book product · Brand (NDA)

NUVARING

ETHINYL ESTRADIOL; ETONOGESTREL

Brand (NDA)NDA 021187TE ABRX ORGANON USA ORGANON

At a glance

Oct 03, 2001

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 03, 2001

    25 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; ETONOGESTREL

Strength

0.015MG/24HR;0.12MG/24HR

Dosage form

RING

Route

VAGINAL

TE code

AB

Application

NDA 021187

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.