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FDA NDA · NDA020974

PROZAC

Sponsor: LILLY

APPLICATION
NDA020974
TYPE
NDA
ORIGINAL APPROVAL
1999-03-09
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROZAC · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PROZAC · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2009-03-13Efficacy · Supplement 2 · standardAP
2009-03-13Labeling · Supplement 3 · standardAP
2006-09-20Labeling · Supplement 8 · standard — Label ↗AP
2006-04-11Labeling · Supplement 7 · standard — Letter ↗AP
2005-12-01Labeling · Supplement 5 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 6 · standard — Letter ↗AP
2004-08-19Labeling · Supplement 4 · standard — Letter ↗AP
2002-07-29Efficacy · Supplement 1 · standard — Review ↗AP
1999-03-09Type 3 - New Dosage Form · Original · standard — 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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