Assyro AI

Orange Book product · Brand (NDA)

ACTIFED W/ CODEINE

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Brand (NDA)NDA 012575DISCN GLAXOSMITHKLINE

At a glance

Apr 04, 1984

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 04, 1984

    42 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Strength

10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

NDA 012575

Product number

003

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.