Assyro AI

Orange Book product · Brand (NDA)

OFORTA

FLUDARABINE PHOSPHATE

Brand (NDA)NDA 022273DISCN SANOFI AVENTIS US
View FLUDARABINE PHOSPHATE familyOpen on FDA Orange Book

At a glance

Dec 18, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 18, 2008

    17 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUDARABINE PHOSPHATE

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022273

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.

Book a Demo