Assyro AI

Orange Book product · Generic (ANDA)

SOMOPHYLLIN-CRT

THEOPHYLLINE

Generic (ANDA)ANDA 087193DISCN GRAHAM DM

At a glance

Approved Prior to Jan 1, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

250MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 087193

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.