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Orange Book product · Generic (ANDA)

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 201336TE AB1RX HERITAGE
View FLUOXETINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Oct 01, 2012

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 01, 2012

    13 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 10MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB1

Application

ANDA 201336

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

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