Assyro AI

Orange Book product · Generic (ANDA)

FLUOROURACIL

FLUOROURACIL

Generic (ANDA)ANDA 209271DISCN INGENUS PHARMS LLC

At a glance

Dec 11, 2019

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 11, 2019

    6 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOROURACIL

Strength

2.5GM/50ML (50MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 209271

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUOROURACIL

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.