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FDA ANDA · ANDA076165

FLUOXETINE HYDROCHLORIDE

Sponsor: CR DOUBLE CRANE

APPLICATION
ANDA076165
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-01
LATEST ACTION
2008-07-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2008-07-07Labeling · Supplement 4AP
2007-10-24Labeling · Supplement 3AP
2006-10-05Labeling · Supplement 2AP
2002-02-01OriginalOther Important Information from FDAAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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