Treats Major Depressive Disorder. NDA 18936, held by Eli Lilly And Co. Fluoxetine Hydrochloride.
As of Nov 14, 2026, NDA 18936 (Prozac, Sarafem), held by Eli Lilly And Co, was first approved by FDA on Dec 29, 1987, with 88 approved supplements and 0 published complete response letters.
PROZAC is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. Acute treatment of Panic Disorder, with or without agoraphobia. PROZAC and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder.
| Oct 10, 2014 | Supplement 102Efficacy (new indication or use) · Standard review | Approved | |
| Jul 26, 2013 | Supplement 101Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2009 | Supplement 77Efficacy (new indication or use) · Priority review | Approved | |
| Jan 3, 2003 | Supplement 64Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 2002 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 2002 | Supplement 65Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2002 | Supplement 67Efficacy (new indication or use) · Standard review | Approved | |
| Jul 6, 2000 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 1996 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Dec 29, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| ProzacEQ 20MG BASE · capsule;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| ProzacEQ 40MG BASE · capsule;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| ProzacEQ 60MG BASE · capsule;oral | Fluoxetine Hydrochloride | Discontinued |
| ProzacEQ 10MG BASE · capsule;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| SarafemEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| SarafemEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| Aug 18, 2023 | Supplement 112Labeling · Standard review | Approved | |
| Oct 6, 2021 | Supplement 111Labeling | Approved | |
| Apr 28, 2020 | Supplement 109Labeling · Standard review | Approved | |
| Mar 24, 2017 | Supplement 103Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 108Labeling | Approved | |
| Aug 1, 2016 | Supplement 107Manufacturing · Priority review | Approved | None posted |
| Nov 24, 2015 | Supplement 106Labeling | Approved | |
| Oct 10, 2014 | Supplement 102Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2014 | Supplement 105Labeling | Approved | |
| Jul 26, 2013 | Supplement 100Labeling | Approved | |
| Jul 26, 2013 | Supplement 101Efficacy (new indication or use) · Standard review | Approved | |
| Jan 3, 2013 | Supplement 97Labeling · Standard review | Approved | |
| Jan 3, 2013 | Supplement 98Labeling · Standard review | Approved | |
| Jun 15, 2011 | Supplement 96Labeling | Approved | |
| Apr 4, 2011 | Supplement 91Labeling · Standard review | Approved | |
| Apr 4, 2011 | Supplement 93Labeling | Approved | |
| Apr 4, 2011 | Supplement 95Labeling | Approved | |
| Jun 22, 2009 | Supplement 89Labeling · Standard review | Approved | |
| Mar 19, 2009 | Supplement 75Labeling · Standard review | Approved | |
| Mar 19, 2009 | Supplement 77Efficacy (new indication or use) · Priority review | Approved | |
| Jan 30, 2009 | Supplement 88Labeling | Approved | |
| Jun 26, 2008 | Supplement 86Labeling · Standard review | Approved | |
| Mar 21, 2008 | Supplement 84Labeling · Standard review | Approved | |
| Mar 9, 2008 | Supplement 83Labeling · Standard review | Approved | |
| Aug 2, 2007 | Supplement 81Labeling · Standard review | Approved | |
| Aug 2, 2007 | Supplement 82Labeling · Standard review | Approved | |
| Mar 15, 2007 | Supplement 78Labeling · Standard review | Approved | |
| Sep 20, 2006 | Supplement 76Labeling · Standard review | Approved | |
| Apr 11, 2006 | Supplement 74Labeling · Standard review | Approved | |
| Dec 1, 2005 | Supplement 71Labeling · Standard review | Approved | |
| Dec 1, 2005 | Supplement 73Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 72Labeling · Standard review | Approved | |
| Sep 3, 2004 | Supplement 70Labeling · Standard review | Approved | |
| Aug 19, 2004 | Supplement 69Labeling · Standard review | Approved | |
| Jan 3, 2003 | Supplement 64Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 2002 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 2002 | Supplement 65Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2002 | Supplement 67Efficacy (new indication or use) · Standard review | Approved | |
| Nov 28, 2000 | Supplement 60Labeling · Standard review | Approved | |
| Nov 28, 2000 | Supplement 62Labeling · Standard review | Approved | |
| Nov 28, 2000 | Supplement 63Labeling · Standard review | Approved | |
| Jul 6, 2000 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 1999 | Supplement 52Labeling · Standard review | Approved | |
| Jun 16, 1999 | Supplement 59Labeling · Standard review | Approved | None posted |
| Jun 15, 1999 | Supplement 54Manufacturing · Priority review | Approved | |
| Feb 11, 1999 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Oct 20, 1998 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Jul 6, 1998 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| May 29, 1998 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Apr 3, 1998 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Mar 13, 1998 | Supplement 51Labeling · Standard review | Approved | None posted |
| Sep 17, 1997 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Mar 25, 1997 | Supplement 36Labeling · Standard review | Approved | |
| Dec 30, 1996 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Nov 21, 1996 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Sep 12, 1995 | Supplement 38Labeling · Standard review | Approved | None posted |
| Sep 12, 1995 | Supplement 40Labeling · Standard review | Approved | None posted |
| Mar 1, 1995 | Supplement 37Labeling · Standard review | Approved | None posted |
| Mar 1, 1995 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Jan 9, 1995 | Supplement 33Manufacturing · Priority review | Approved | |
| Jul 6, 1994 | Supplement 34Labeling · Standard review | Approved | None posted |
| Aug 18, 1993 | Supplement 31Labeling · Standard review | Approved | None posted |
| Mar 25, 1993 | Supplement 32Labeling · Standard review | Approved | None posted |
| Dec 23, 1992 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 20, 1992 | Supplement 30Labeling | Approved | None posted |
| Jan 21, 1992 | Supplement 25Labeling | Approved | None posted |
| Jan 21, 1992 | Supplement 27Labeling | Approved | None posted |
| Jan 21, 1992 | Supplement 28Labeling | Approved | None posted |
| Apr 9, 1991 | Supplement 23Labeling | Approved | None posted |
| Apr 9, 1991 | Supplement 24Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 15Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 16Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 17Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 18Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 19Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 20Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 21Labeling | Approved | None posted |
| Jun 7, 1990 | Supplement 22Labeling | Approved | None posted |
| Feb 17, 1989 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Feb 16, 1989 | Supplement 13Labeling | Approved | None posted |
| Feb 8, 1989 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Nov 17, 1988 | Supplement 9Labeling | Approved | None posted |
| Nov 17, 1988 | Supplement 11Labeling | Approved | None posted |
| Oct 26, 1988 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Sep 28, 1988 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Sep 28, 1988 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 22, 1988 | Supplement 7Labeling | Approved | None posted |
| May 6, 1988 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Dec 29, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
