Assyro AI

Orange Book product · Generic (ANDA)

POLMON

DEXCHLORPHENIRAMINE MALEATE

Generic (ANDA)ANDA 202520RX PHARMOBEDIENT

At a glance

Jul 16, 2018

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 16, 2018

    8 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXCHLORPHENIRAMINE MALEATE

Strength

2MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 202520

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DEXCHLORPHENIRAMINE MALEATE

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.