Assyro AI

Orange Book product · Generic (ANDA)

SLO-PHYLLIN

THEOPHYLLINE

Generic (ANDA)ANDA 085203DISCN SANOFI AVENTIS US

At a glance

May 24, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 24, 1982

    44 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

125MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 085203

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.