Assyro AI

Orange Book product · Generic (ANDA)

GRISEOFULVIN

GRISEOFULVIN, MICROSIZE

Generic (ANDA)ANDA 065394TE ABRX ACTAVIS MID ATLANTIC

At a glance

Jul 06, 2007

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 06, 2007

    19 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GRISEOFULVIN, MICROSIZE

Strength

125MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

AB

Application

ANDA 065394

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.