Treats schizophrenia. NDA 21253, held by Cheplapharm. Olanzapine.
As of Nov 14, 2026, NDA 21253 (Zyprexa), held by Cheplapharm, was first approved by FDA on Mar 29, 2004, with 27 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 |
|---|---|---|---|
| Mar 29, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zyprexa10MG/VIAL · powder;intramuscular | Olanzapine | RxReference drug |
| Jan 30, 2026 | Supplement 67Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 66Labeling · Standard review | Approved | |
| Apr 23, 2020 | Supplement 61Labeling · Standard review | Approved | |
| Apr 21, 2020 | Supplement 62Labeling | Approved | |
| Oct 22, 2019 | Supplement 60Labeling · Standard review | Approved | |
| Mar 27, 2018 | Supplement 59Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 58Labeling | Approved | |
| Feb 23, 2017 | Supplement 57Labeling · Standard review | Approved | |
| Oct 27, 2016 | Supplement 55Manufacturing | Approved | None posted |
| Oct 6, 2016 | Supplement 56Labeling | Approved | |
| Jul 23, 2015 | Supplement 49Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 48Labeling · Standard review | Approved | |
| Sep 30, 2014 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Aug 11, 2014 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Dec 1, 2010 | Supplement 45Labeling | Approved | |
| May 27, 2010 | Supplement 43Labeling | Approved | |
| May 27, 2010 | Supplement 39Labeling | Approved | |
| Jan 27, 2010 | Supplement 37Labeling | Approved | |
| Aug 31, 2009 | Supplement 36Labeling | Approved | |
| Aug 14, 2008 | Supplement 33Labeling · Standard review | Approved | |
| Jul 6, 2007 | Supplement 26Labeling · Standard review | Approved | |
| Nov 29, 2006 | Supplement 21Labeling · Standard review | Approved | |
| Aug 25, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Feb 23, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Sep 13, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Mar 29, 2004 | Original applicationNew dosage form · 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
