Assyro AI

Orange Book product · Generic (ANDA)

GRISEOFULVIN, ULTRAMICROSIZE

GRISEOFULVIN, ULTRAMICROSIZE

Generic (ANDA)ANDA 202805TE ABRX SANDOZ

At a glance

Dec 26, 2018

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 26, 2018

    7 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GRISEOFULVIN, ULTRAMICROSIZE

Strength

125MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 202805

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GRISEOFULVIN, ULTRAMICROSIZE

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.