Treats schizophrenia. NDA 20592, held by Cheplapharm. Olanzapine.
As of Nov 13, 2026, NDA 20592 (Zyprexa), held by Cheplapharm, was first approved by FDA on Sep 30, 1996, with 48 approved supplements and 0 published complete response letters.
ZYPREXA (olanzapine) is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia. The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2013 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Dec 4, 2009 | Supplement 40Efficacy (new indication or use) · Priority review | Approved | |
| Dec 4, 2009 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Mar 19, 2009 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | |
| Jan 14, 2004 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2003 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2000 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 17, 2000 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 30, 1996 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zyprexa2.5MG · tablet;oral | Olanzapine | RxReference drug |
| Zyprexa5MG · tablet;oral | Olanzapine | RxReference drug |
| Zyprexa7.5MG · tablet;oral | Olanzapine | RxReference drug |
| Zyprexa10MG · tablet;oral | Olanzapine | RxReference drug |
| Zyprexa15MG · tablet;oral | Olanzapine | RxReference drug |
| Zyprexa20MG · tablet;oral | Olanzapine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2026 | Supplement 81Manufacturing | Approved | |
| Jan 30, 2026 | Supplement 79Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 77Labeling · Standard review | Approved | |
| Apr 23, 2020 | Supplement 74Labeling · Standard review | Approved | |
| Apr 21, 2020 | Supplement 75Labeling | Approved | |
| Oct 22, 2019 | Supplement 72Labeling · Standard review | Approved | |
| Mar 27, 2018 | Supplement 71Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 69Labeling | Approved | |
| Feb 23, 2017 | Supplement 68Labeling · Standard review | Approved | |
| Oct 6, 2016 | Supplement 67Labeling | Approved | |
| Jul 23, 2015 | Supplement 64Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 62Labeling · Standard review | Approved | |
| Oct 25, 2013 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Oct 21, 2013 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Jul 26, 2013 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Jun 21, 2011 | Supplement 61REMS | Approved | |
| Jun 21, 2011 | Supplement 60REMS | Approved | |
| Dec 1, 2010 | Supplement 57Labeling | Approved | |
| May 27, 2010 | Supplement 55Labeling | Approved | |
| May 27, 2010 | Supplement 53Labeling | Approved | |
| Jan 27, 2010 | Supplement 52Labeling | Approved | |
| Dec 4, 2009 | Supplement 40Efficacy (new indication or use) · Priority review | Approved | |
| Dec 4, 2009 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2009 | Supplement 51Labeling | Approved | |
| Mar 19, 2009 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | |
| Aug 14, 2008 | Supplement 49Labeling · Standard review | Approved | |
| Jul 6, 2007 | Supplement 43Labeling · Standard review | Approved | |
| Jul 6, 2007 | Supplement 42Labeling · Standard review | Approved | |
| Nov 29, 2006 | Supplement 38Labeling · Standard review | Approved | |
| Aug 25, 2006 | Supplement 29Labeling · Standard review | Approved | |
| Feb 23, 2006 | Supplement 35Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 27Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 32Labeling · Standard review | Approved | |
| Sep 13, 2005 | Supplement 34Labeling · Standard review | Approved | |
| Aug 3, 2005 | Supplement 26Labeling · Standard review | Approved | |
| Jun 29, 2005 | Supplement 20Labeling · Standard review | Approved | |
| Jan 14, 2004 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2003 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jan 22, 2002 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2001 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 9, 2000 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 17, 2000 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jan 11, 1999 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 23, 1998 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 4, 1997 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1997 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1997 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1996 | Original applicationNew molecular entity · Standard review | Approved |
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
