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Orange Book product · Generic (ANDA)

SODIUM FLUORIDE F-18

SODIUM FLUORIDE F-18

Generic (ANDA)ANDA 204497TE APRX UNIV UTAH CYCLOTRON

At a glance

Apr 20, 2015

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 20, 2015

    11 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM FLUORIDE F-18

Strength

10-200mCi/ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 204497

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SODIUM FLUORIDE 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.