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FDA ANDA · ANDA075662

FLUOXETINE

Sponsor: WATSON LABS

APPLICATION
ANDA075662
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2021-10-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FLUOXETINEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
FLUOXETINEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2021-10-08Labeling · Supplement 2 · standardAP
2021-08-26Labeling · Supplement 1 · standardAP
2002-01-29OriginalOther Important Information from FDAAP
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