Assyro AI

Orange Book product · Generic (ANDA)

PLERIXAFOR

PLERIXAFOR

Generic (ANDA)ANDA 215334TE APRX AMNEAL

At a glance

Jul 24, 2023

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 24, 2023

    2 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PLERIXAFOR

Strength

24MG/1.2ML (20MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

AP

Application

ANDA 215334

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PLERIXAFOR

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.