← FDA Drug Approvals (Drugs@FDA)

FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SCIEGEN PHARMS · Approved 2002-06-27

Drug application

FDA Application #

ANDA075525

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOXETINE HYDROCHLORIDE

Generic name

FLUOXETINE

Active ingredients

FLUOXETINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

SCIEGEN PHARMS

Manufacturer

Saptalis Pharmaceuticals, LLC.

First approval

2002-06-27

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown