Assyro AI

Orange Book product · Generic (ANDA)

DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX

Generic (ANDA)ANDA 091135OTC TRIS PHARMA INC

At a glance

May 25, 2012

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 25, 2012

    14 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXTROMETHORPHAN POLISTIREX

Strength

EQ 30MG HYDROBROMIDE/5ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 091135

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DEXTROMETHORPHAN 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.