Assyro AI

Orange Book product · Generic (ANDA)

FAMCICLOVIR

FAMCICLOVIR

Generic (ANDA)ANDA 091480TE ABRX APOTEX

At a glance

Jul 22, 2011

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 22, 2011

    15 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FAMCICLOVIR

Strength

125MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 091480

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FAMCICLOVIR

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.