Assyro AI

Orange Book product · Generic (ANDA)

PENCICLOVIR

PENCICLOVIR

Generic (ANDA)ANDA 214100TE ABRX AMNEAL

At a glance

Aug 22, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 22, 2025

    10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PENCICLOVIR

Strength

1%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

ANDA 214100

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PENCICLOVIR

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.