Assyro AI

Orange Book product · Brand (NDA)

CODEPREX

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Brand (NDA)NDA 021369DISCN LANNETT CO INC

At a glance

Jun 21, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 21, 2004

    22 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Strength

EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 021369

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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.