Assyro AI

Orange Book product · Generic (ANDA)

THEO-24

THEOPHYLLINE

Generic (ANDA)ANDA 087943RX ENDO OPERATIONS

At a glance

Feb 28, 1992

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 28, 1992

    34 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

400MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 087943

Product number

004

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.