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FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2009-03-19

Drug application

FDA Application #
ANDA090223
Application type
Abbreviated New Drug Application (Generic)
Brand name
FLUOXETINE HYDROCHLORIDE
Generic name
FLUOXETINE
Active ingredients
FLUOXETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
ALEMBIC PHARMS LTD
Manufacturer
Alembic Pharmaceuticals Limited
First approval
2009-03-19

Source

Authoritative
Drugs@FDA application overview
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