Assyro AI

Orange Book product · Brand (NDA)

LANOXICAPS

DIGOXIN

Brand (NDA)NDA 018118DISCN GLAXOSMITHKLINE LLC

At a glance

Jul 26, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 1982

    44 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DIGOXIN

Strength

0.2MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 018118

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.