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OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EPIC PHARMA LLC · Approved 2012-11-16

Drug application

FDA Application #

ANDA078901

Application type

Abbreviated New Drug Application (Generic)

Brand name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Generic name

Fluoxetine Hydrochloride

Active ingredients

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

EPIC PHARMA LLC

First approval

2012-11-16

Source

Authoritative

Drugs@FDA application overview

Machine

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