Assyro AI

Orange Book product · Generic (ANDA)

FLUVOXAMINE MALEATE

FLUVOXAMINE MALEATE

Generic (ANDA)ANDA 091482TE ABRX ACTAVIS ELIZABETH

At a glance

Nov 18, 2013

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 18, 2013

    12 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUVOXAMINE MALEATE

Strength

150MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 091482

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.