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FDA NDA · NDA020101

PROZAC

Sponsor: LILLY

APPLICATION
NDA020101
TYPE
NDA
ORIGINAL APPROVAL
1991-04-24
LATEST ACTION
2009-01-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PROZAC · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2009-01-30Labeling · Supplement 42 · priority — Letter ↗AP
2008-03-21Labeling · Supplement 39 · priority — Label ↗AP
2008-03-09Labeling · Supplement 38 · priority — Letter ↗AP
2007-08-02Labeling · Supplement 37 · priority — Label ↗AP
2007-03-15Labeling · Supplement 36 · priority — Letter ↗AP
2006-09-20Labeling · Supplement 35 · priority — Label ↗AP
2006-04-11Labeling · Supplement 34 · priority — Letter ↗AP
2005-12-01Labeling · Supplement 32 · priority — Letter ↗AP
2005-02-18Labeling · Supplement 33 · priority — Letter ↗AP
2004-08-19Labeling · Supplement 31 · priority — Letter ↗AP
2004-05-25Manufacturing (CMC) · Supplement 29 · priority — Letter ↗AP
2002-07-29Efficacy · Supplement 27 · priorityAP
1999-10-07Labeling · Supplement 24 · priority — Review ↗AP
1999-06-16Labeling · Supplement 26 · priorityAP
1998-08-04Manufacturing (CMC) · Supplement 23 · priorityAP
1998-08-04Manufacturing (CMC) · Supplement 22 · priorityAP
1998-04-23Manufacturing (CMC) · Supplement 20 · priorityAP
1998-03-13Labeling · Supplement 21 · priorityAP
1997-03-25Labeling · Supplement 9 · priorityAP
1996-04-01Manufacturing (CMC) · Supplement 14 · priorityAP
1995-09-12Labeling · Supplement 12 · priorityAP
1995-09-12Labeling · Supplement 11 · priorityAP
1995-05-22Manufacturing (CMC) · Supplement 6 · priorityAP
1995-03-01Labeling · Supplement 10 · priorityAP
1994-07-06Labeling · Supplement 7 · priorityAP
1993-08-18Labeling · Supplement 4 · priorityAP
1993-03-25Labeling · Supplement 5 · priorityAP
1992-08-20Labeling · Supplement 3 · priorityAP
1992-01-21Labeling · Supplement 2 · priorityAP
1992-01-21Labeling · Supplement 1 · priorityAP
1991-04-24Type 3 - New Dosage Form · Original · priority — Other Important Information from FDA ↗AP
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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