Assyro AI

Orange Book product · Generic (ANDA)

DIGOXIN

DIGOXIN

Generic (ANDA)ANDA 077002TE ABRX HIKMA INTL PHARMS

At a glance

Oct 30, 2007

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 30, 2007

    18 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DIGOXIN

Strength

0.125MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 077002

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DIGOXIN

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.