Assyro AI

Orange Book product · Generic (ANDA)

LINEZOLID

LINEZOLID

Generic (ANDA)ANDA 205517TE ABRX ALKEM LABS LTD

At a glance

Dec 21, 2015

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 21, 2015

    10 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LINEZOLID

Strength

600MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 205517

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.