Assyro AI

Orange Book product · Brand (NDA)

NORTHERA

DROXIDOPA

Brand (NDA)NDA 203202TE ABRX LUNDBECK NA LTD

At a glance

Feb 18, 2014

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 18, 2014

    12 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DROXIDOPA

Strength

100MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 203202

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.