Assyro AI

Orange Book product · Generic (ANDA)

VALRUBICIN

VALRUBICIN

Generic (ANDA)ANDA 206430TE AORX HIKMA

At a glance

Apr 19, 2019

Approved

Generic (ANDA)

Application

AO

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 19, 2019

    7 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VALRUBICIN

Strength

40MG/ML

Dosage form

SOLUTION

Route

INTRAVESICAL

TE code

AO

Application

ANDA 206430

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of VALRUBICIN

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.