Assyro AI

Orange Book product · Brand (NDA)

PURIXAN

MERCAPTOPURINE

Brand (NDA)NDA 205919TE ABRX NOVA LABS LTD

At a glance

Apr 28, 2014

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 28, 2014

    12 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MERCAPTOPURINE

Strength

20MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

AB

Application

NDA 205919

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.