Assyro AI

Orange Book product · Generic (ANDA)

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Generic (ANDA)ANDA 091632RX TRIS PHARMA INC

At a glance

Oct 01, 2010

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 01, 2010

    15 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Strength

EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 091632

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

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.