Assyro AI

Orange Book product · Generic (ANDA)

CLOFARABINE

CLOFARABINE

Generic (ANDA)ANDA 212034TE APRX ACCORD HLTHCARE

At a glance

Feb 22, 2019

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 22, 2019

    7 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLOFARABINE

Strength

20MG/20ML (1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 212034

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CLOFARABINE

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.