Assyro AI

Orange Book product · Generic (ANDA)

GRIFULVIN V

GRISEOFULVIN, MICROSIZE

Generic (ANDA)ANDA 062483DISCN VALEANT LUXEMBOURG

At a glance

Jan 26, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 26, 1984

    43 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

GRISEOFULVIN, MICROSIZE

Strength

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 062483

Product number

001

Marketing status

DISCN

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.