Assyro AI

Orange Book product · Generic (ANDA)

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 075525TE AARX SCIEGEN PHARMS

At a glance

Jun 27, 2002

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 27, 2002

    24 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 20MG BASE/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 075525

Product number

001

Marketing status

RX

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.