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FDA ANDA · ANDA075577

FLUOXETINE HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA075577
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2024-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2024-06-12Labeling · Supplement 15 · standardAP
2024-06-12Labeling · Supplement 14 · standardAP
2009-07-06Labeling · Supplement 11AP
2008-10-08Labeling · Supplement 10AP
2008-04-17Labeling · Supplement 9AP
2007-09-12Labeling · Supplement 8AP
2007-09-12Labeling · Supplement 7AP
2006-02-28Labeling · Supplement 6AP
2005-05-17Labeling · Supplement 4AP
2005-05-17Labeling · Supplement 3AP
2002-01-29Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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