Assyro AI

Orange Book product · Generic (ANDA)

PODOFILOX

PODOFILOX

Generic (ANDA)ANDA 211871RX PADAGIS US

At a glance

Nov 22, 2023

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 22, 2023

    2 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PODOFILOX

Strength

0.5%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

ANDA 211871

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of PODOFILOX

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.