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FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IVAX SUB TEVA PHARMS · Approved 2002-01-31

Drug application

FDA Application #
ANDA075245
Application type
Abbreviated New Drug Application (Generic)
Brand name
FLUOXETINE HYDROCHLORIDE
Generic name
Fluoxetine Hydrochloride
Active ingredients
FLUOXETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
IVAX SUB TEVA PHARMS
First approval
2002-01-31

Source

Authoritative
Drugs@FDA application overview
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