Assyro AI

Orange Book product · Generic (ANDA)

GRISEOFULVIN

GRISEOFULVIN, MICROSIZE

Generic (ANDA)ANDA 065438TE ABRX COSETTE PHARMS NC

At a glance

Oct 08, 2010

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 08, 2010

    15 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GRISEOFULVIN, MICROSIZE

Strength

125MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

AB

Application

ANDA 065438

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, MICROSIZE

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.