Assyro AI

Orange Book product · Generic (ANDA)

FLUOXETINE

FLUOXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 075787DISCN SUN PHARM INDUSTRIES

At a glance

Jan 29, 2002

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 29, 2002

    24 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 10MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 075787

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUOXETINE HYDROCHLORIDE

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.