Assyro AI

Orange Book product · Generic (ANDA)

OXALIPLATIN

OXALIPLATIN

Generic (ANDA)ANDA 078812DISCN SANDOZ

At a glance

Aug 07, 2009

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 07, 2009

    17 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OXALIPLATIN

Strength

50MG/10ML (5MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 078812

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of OXALIPLATIN

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.