Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018936
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription AB1 Yes No
PROZAC FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription AB Yes Yes
PROZAC FLUOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Discontinued None No No
PROZAC FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription AB1 Yes No
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
12/29/1987 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/04/2017 SUPPL-108 Labeling-Medication Guide Label (PDF)
Letter (PDF)
Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s108,021235Orig1s026,021520Orig1s047ltr.pdf
08/01/2016 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

11/24/2015 SUPPL-106 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018936Orig1s106ltr.pdf
07/18/2014 SUPPL-105 Labeling-Package Insert Label (PDF)
Letter (PDF)
Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf
03/24/2017 SUPPL-103 Labeling-Package Insert Label (PDF)
Letter (PDF)
Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s103,021235Orig1s023,021520Orig1s042ltr.pdf
10/10/2014 SUPPL-102 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf
07/26/2013 SUPPL-101 Efficacy-Pediatric Label (PDF)
Letter (PDF)
Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf
07/26/2013 SUPPL-100 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf
01/03/2013 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf
01/03/2013 SUPPL-97 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018936Orig1s097.pdf
06/15/2011 SUPPL-96 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf
04/04/2011 SUPPL-95 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf
04/04/2011 SUPPL-93 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/018936Orig1s093.pdf
04/04/2011 SUPPL-91 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf
06/22/2009 SUPPL-89 Labeling Label (PDF)
Letter (PDF)
Label for SARAFEM https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s089ltr.pdf
01/30/2009 SUPPL-88 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
06/26/2008 SUPPL-86 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s086ltr.pdf
03/21/2008 SUPPL-84 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-83 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-82 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
08/02/2007 SUPPL-81 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-78 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/018936Orig1s078.pdf
03/19/2009 SUPPL-77 Efficacy-Labeling Change With Clinical Data, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf
09/20/2006 SUPPL-76 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf
03/19/2009 SUPPL-75 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf
04/11/2006 SUPPL-74 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf
12/01/2005 SUPPL-73 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
02/18/2005 SUPPL-72 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-71 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
09/03/2004 SUPPL-70 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18936s070ltr.pdf
08/19/2004 SUPPL-69 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf
06/12/2002 SUPPL-67 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18936s067ltr.pdf
07/29/2002 SUPPL-65 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

01/03/2003 SUPPL-64 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18936se5-064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/18936s064_Prozac.cfm
11/28/2000 SUPPL-63 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm
11/28/2000 SUPPL-62 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm
07/29/2002 SUPPL-61 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974s1lbl.pdf
11/28/2000 SUPPL-60 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm
06/16/1999 SUPPL-59 Labeling

Label is not available on this site.

07/06/2000 SUPPL-58 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18936S58LTR.PDF
02/11/1999 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

10/20/1998 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1999 SUPPL-54 Manufacturing (CMC)-Formulation Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936s054_Prozac.cfm
05/29/1998 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

10/07/1999 SUPPL-52 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936S052_20-101S024_Prozac.cfm
03/13/1998 SUPPL-51 Labeling

Label is not available on this site.

07/06/1998 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

04/03/1998 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/1997 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/12/1995 SUPPL-40 Labeling

Label is not available on this site.

03/01/1995 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1995 SUPPL-38 Labeling

Label is not available on this site.

03/01/1995 SUPPL-37 Labeling

Label is not available on this site.

03/25/1997 SUPPL-36 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18936S036_ProzacPulvules.pdf
07/06/1994 SUPPL-34 Labeling

Label is not available on this site.

01/09/1995 SUPPL-33 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018936_S033_PROZAC.pdf
03/25/1993 SUPPL-32 Labeling

Label is not available on this site.

08/18/1993 SUPPL-31 Labeling

Label is not available on this site.

08/20/1992 SUPPL-30 Labeling

Label is not available on this site.

01/21/1992 SUPPL-28 Labeling

Label is not available on this site.

01/21/1992 SUPPL-27 Labeling

Label is not available on this site.

12/23/1992 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/21/1992 SUPPL-25 Labeling

Label is not available on this site.

04/09/1991 SUPPL-24 Labeling

Label is not available on this site.

04/09/1991 SUPPL-23 Labeling

Label is not available on this site.

06/07/1990 SUPPL-22 Labeling

Label is not available on this site.

06/07/1990 SUPPL-21 Labeling

Label is not available on this site.

06/07/1990 SUPPL-20 Labeling

Label is not available on this site.

06/07/1990 SUPPL-19 Labeling

Label is not available on this site.

06/07/1990 SUPPL-18 Labeling

Label is not available on this site.

06/07/1990 SUPPL-17 Labeling

Label is not available on this site.

06/07/1990 SUPPL-16 Labeling

Label is not available on this site.

06/07/1990 SUPPL-15 Labeling

Label is not available on this site.

02/08/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1989 SUPPL-13 Labeling

Label is not available on this site.

02/17/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1988 SUPPL-11 Labeling

Label is not available on this site.

11/17/1988 SUPPL-9 Labeling

Label is not available on this site.

10/26/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-7 Labeling

Label is not available on this site.

09/28/1988 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/1996 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

09/28/1988 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1988 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-103 Labeling-Package Insert Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf
01/04/2017 SUPPL-108 Labeling-Medication Guide Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf
10/10/2014 SUPPL-102 Efficacy-Labeling Change With Clinical Data Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf
07/18/2014 SUPPL-105 Labeling-Package Insert Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf
07/26/2013 SUPPL-101 Efficacy-Pediatric Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf
07/26/2013 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf
01/03/2013 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf
01/03/2013 SUPPL-97 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf
06/15/2011 SUPPL-96 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf
04/04/2011 SUPPL-95 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf
04/04/2011 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf
04/04/2011 SUPPL-91 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf
06/22/2009 SUPPL-89 Labeling Label (PDF) Label for SARAFEM https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf
03/19/2009 SUPPL-77 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
03/19/2009 SUPPL-77 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
03/19/2009 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
01/30/2009 SUPPL-88 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf
06/26/2008 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf
03/21/2008 SUPPL-84 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf
03/09/2008 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf
08/02/2007 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf
08/02/2007 SUPPL-81 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf
09/20/2006 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf
01/03/2003 SUPPL-64 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf
07/29/2002 SUPPL-61 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974s1lbl.pdf
06/12/2002 SUPPL-67 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf
07/06/2000 SUPPL-58 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF

PROZAC

CAPSULE;ORAL; EQ 20MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 090223 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 078619 AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 074803 BARR
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 201336 HERITAGE PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075245 IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075464 LANDELA PHARM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075465 MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075049 SANDOZ
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075658 SPECGX LLC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075452 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 076001 TEVA PHARMS USA
PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription Yes AB1 018936 ELI LILLY AND CO

CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 090223 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 078619 AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 201336 HERITAGE PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075245 IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075465 MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 076922 PAR PHARM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075049 SANDOZ
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 076990 SUN PHARM INDS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075452 TEVA
PROZAC FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription Yes AB 018936 ELI LILLY AND CO

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 090223 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 078619 AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 074803 BARR
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 201336 HERITAGE PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075245 IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075464 LANDELA PHARM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075465 MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075049 SANDOZ
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075658 SPECGX LLC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075452 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 076001 TEVA PHARMS USA
PROZAC FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription Yes AB1 018936 ELI LILLY AND CO

SARAFEM

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English