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FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS · Approved 2022-03-29

Drug application

FDA Application #
ANDA216232
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
MICRO LABS
Manufacturer
Micro Labs Limited
First approval
2022-03-29

Source

Authoritative
Drugs@FDA application overview
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