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Orange Book product · Generic (ANDA)

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 203836TE ABRX PH HEALTH
View FLUOXETINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 19, 2016

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 19, 2016

    10 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 10MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 203836

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.

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