Assyro AI

Orange Book product · Generic (ANDA)

FOMEPIZOLE

FOMEPIZOLE

Generic (ANDA)ANDA 079033DISCN MYLAN INSTITUTIONAL

At a glance

Apr 07, 2009

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 07, 2009

    17 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FOMEPIZOLE

Strength

1.5GM/1.5ML (1GM/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 079033

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FOMEPIZOLE

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.