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Orange Book product · Generic (ANDA)

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 078619TE ABRX AUROBINDO PHARMA
View FLUOXETINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 31, 2008

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 2008

    18 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 40MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 078619

Product number

003

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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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