Assyro AI

Orange Book product · Generic (ANDA)

FLUVOXAMINE MALEATE

FLUVOXAMINE MALEATE

Generic (ANDA)ANDA 075901DISCN ACTAVIS ELIZABETH

At a glance

Dec 28, 2000

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 28, 2000

    25 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUVOXAMINE MALEATE

Strength

25MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 075901

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUVOXAMINE MALEATE

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.