Assyro AI

Orange Book product · Generic (ANDA)

THEOPHYLLINE

THEOPHYLLINE

Generic (ANDA)ANDA 087449DISCN ROXANE

At a glance

Sep 15, 1983

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 1983

    43 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

80MG/15ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 087449

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of THEOPHYLLINE

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.