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FDA ANDA · ANDA074803

FLUOXETINE HYDROCHLORIDE

Sponsor: BARR

APPLICATION
ANDA074803
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-02
LATEST ACTION
2010-05-24
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

2010-05-24Labeling · Supplement 23AP
2009-07-14Labeling · Supplement 22AP
2008-09-25Labeling · Supplement 21AP
2008-03-17Labeling · Supplement 19AP
2008-03-17Labeling · Supplement 18AP
2005-08-25Labeling · Supplement 16AP
2005-08-25Labeling · Supplement 14AP
2003-11-26Labeling · Supplement 11AP
2002-11-26Manufacturing (CMC) · Supplement 10AP
2002-01-30Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2002-01-30Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2002-01-30Labeling · Supplement 4 — Letter ↗AP
2002-01-30Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2002-01-30Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2002-01-30Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2001-12-13Manufacturing (CMC) · Supplement 2AP
2001-12-13Manufacturing (CMC) · Supplement 3AP
2001-12-13Manufacturing (CMC) · Supplement 1AP
2001-08-02Original — Review ↗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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