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FDA ANDA · ANDA075787

FLUOXETINE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA075787
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2007-06-29
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

2007-06-29Labeling · Supplement 11AP
2007-06-29Labeling · Supplement 12AP
2005-06-30Labeling · Supplement 4AP
2002-01-29OriginalOther 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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