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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020101
Company: LILLY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/24/1991 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2009 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf
03/21/2008 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf
03/09/2008 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf
08/02/2007 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf
03/15/2007 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf
09/20/2006 SUPPL-35 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf
04/11/2006 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf
02/18/2005 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf
12/01/2005 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf
08/19/2004 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf
05/25/2004 SUPPL-29 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20101scm029ltr.pdf
07/29/2002 SUPPL-27 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.
06/16/1999 SUPPL-26 Labeling

Label is not available on this site.
10/07/1999 SUPPL-24 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936S052_20-101S024_Prozac.cfm
08/04/1998 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
08/04/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
03/13/1998 SUPPL-21 Labeling

Label is not available on this site.
04/23/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
04/01/1996 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/12/1995 SUPPL-12 Labeling

Label is not available on this site.
09/12/1995 SUPPL-11 Labeling

Label is not available on this site.
03/01/1995 SUPPL-10 Labeling

Label is not available on this site.
03/25/1997 SUPPL-9 Labeling

Label is not available on this site.
07/06/1994 SUPPL-7 Labeling

Label is not available on this site.
05/22/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
03/25/1993 SUPPL-5 Labeling

Label is not available on this site.
08/18/1993 SUPPL-4 Labeling

Label is not available on this site.
08/20/1992 SUPPL-3 Labeling

Label is not available on this site.
01/21/1992 SUPPL-2 Labeling

Label is not available on this site.
01/21/1992 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/30/2009 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf
03/21/2008 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf
03/09/2008 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf
08/02/2007 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf
09/20/2006 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf
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