Assyro AI

Orange Book product · Generic (ANDA)

DEXCHLORPHENIRAMINE MALEATE

DEXCHLORPHENIRAMINE MALEATE

Generic (ANDA)ANDA 088251DISCN PAI HOLDINGS PHARM

At a glance

Mar 23, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 23, 1984

    42 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXCHLORPHENIRAMINE MALEATE

Strength

2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 088251

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.