Assyro AI

Orange Book product · Generic (ANDA)

THEOPHYL

THEOPHYLLINE

Generic (ANDA)ANDA 086506DISCN ORTHO MCNEIL PHARM

At a glance

Sep 12, 1985

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 12, 1985

    41 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

100MG

Dosage form

TABLET, CHEWABLE

Route

ORAL

TE code

Not listed

Application

ANDA 086506

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

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.