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Orange Book product · Generic (ANDA)

FLUDEOXYGLUCOSE F18

FLUDEOXYGLUCOSE F-18

Generic (ANDA)ANDA 203778TE APRX 3D IMAGING DRUG

At a glance

Oct 30, 2015

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 30, 2015

    10 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUDEOXYGLUCOSE F-18

Strength

20-300mCi/ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 203778

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUDEOXYGLUCOSE F-18

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.