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Orange Book product · Generic (ANDA)

OXALIPLATIN

OXALIPLATIN

Generic (ANDA)ANDA 091358TE APRX MYLAN LABS LTD
View OXALIPLATIN familyOpen on FDA Orange Book

At a glance

Aug 07, 2012

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 07, 2012

    14 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OXALIPLATIN

Strength

50MG/10ML (5MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 091358

Product number

001

Marketing status

RX

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

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