Assyro AI

Orange Book product · Brand (NDA)

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

THEOPHYLLINE

Brand (NDA)NDA 018649DISCN BAXTER HLTHCARE

At a glance

Nov 13, 1985

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 13, 1985

    41 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

320MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 018649

Product number

006

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.