Assyro AI

Orange Book product · Generic (ANDA)

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 078045DISCN NATCO PHARMA USA
View FLUOXETINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Nov 17, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 17, 2008

    17 yr 10 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 078045

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.

Book a Demo