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FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2022-11-09

Drug application

FDA Application #

ANDA216448

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOXETINE HYDROCHLORIDE

Generic name

FLUOXETINE HYDROCHLORIDE

Active ingredients

FLUOXETINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2022-11-09

Source

Authoritative

Drugs@FDA application overview

Machine

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