Assyro AI

Orange Book product · Generic (ANDA)

LINEZOLID

LINEZOLID

Generic (ANDA)ANDA 200904TE APRX SANDOZ

At a glance

Jul 16, 2015

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 16, 2015

    11 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LINEZOLID

Strength

200MG/100ML (2MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 200904

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LINEZOLID

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.