Assyro AI

Orange Book product · Generic (ANDA)

CLOFARABINE

CLOFARABINE

Generic (ANDA)ANDA 207831TE APRX GLAND

At a glance

Oct 31, 2018

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 31, 2018

    7 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLOFARABINE

Strength

20MG/20ML (1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 207831

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.