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FDA NDA · NDA021235

PROZAC WEEKLY

Sponsor: LILLY

APPLICATION
NDA021235
TYPE
NDA
ORIGINAL APPROVAL
2001-02-26
LATEST ACTION
2017-03-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued

Products

PROZAC WEEKLY · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2017-03-24Labeling · Supplement 23 · standard — Label ↗AP
2017-01-04Labeling · Supplement 26 · 901 required — Label ↗AP
2015-08-04Labeling · Supplement 25 · standard — Label ↗AP
2014-07-18Labeling · Supplement 24 · 901 required — Letter ↗AP
2013-07-26Labeling · Supplement 21 · unknown — Label ↗AP
2013-01-03Labeling · Supplement 19 · standard — Label ↗AP
2013-01-03Labeling · Supplement 20 · standard — Letter ↗AP
2011-06-15Labeling · Supplement 18 · standard — Letter ↗AP
2011-04-04Labeling · Supplement 17 · unknown — Label ↗AP
2011-04-04Labeling · Supplement 15 · standard — Label ↗AP
2011-04-04Labeling · Supplement 16 · unknown — Letter ↗AP
2009-01-30Labeling · Supplement 14 · 901 required — Letter ↗AP
2008-03-21Labeling · Supplement 11 · standard — Label ↗AP
2008-03-09Labeling · Supplement 10 · standard — Label ↗AP
2007-08-02Labeling · Supplement 9 · standard — Label ↗AP
2007-03-15Labeling · Supplement 8 · standard — Letter ↗AP
2006-09-20Labeling · Supplement 7 · standard — Label ↗AP
2006-04-11Labeling · Supplement 6 · standard — Letter ↗AP
2005-12-01Labeling · Supplement 3 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 4 · standard — Letter ↗AP
2004-08-19Labeling · Supplement 2 · standard — Letter ↗AP
2001-02-26Type 3 - New Dosage Form · Original · standard — 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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