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Orange Book product · Generic (ANDA)

FLUDARABINE PHOSPHATE

FLUDARABINE PHOSPHATE

Generic (ANDA)ANDA 090724TE AP1RX AREVA PHARMS
View FLUDARABINE PHOSPHATE familyOpen on FDA Orange Book

At a glance

Sep 27, 2010

Approved

Generic (ANDA)

Application

AP1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 27, 2010

    15 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUDARABINE PHOSPHATE

Strength

50MG/2ML (25MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP1

Application

ANDA 090724

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUDARABINE PHOSPHATE

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.

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