Treats schizophrenia. NDA 21086, held by Cheplapharm. Olanzapine.
As of Nov 15, 2026, NDA 21086 (Zyprexa Zydis), held by Cheplapharm, was first approved by FDA on Apr 6, 2000, with 30 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.
| Jul 26, 2013 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2009 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Apr 6, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Zyprexa Zydis5MG · tablet, orally disintegrating;oral | Olanzapine | RxReference drug |
| Zyprexa Zydis10MG · tablet, orally disintegrating;oral | Olanzapine | RxReference drug |
| Zyprexa Zydis15MG · tablet, orally disintegrating;oral | Olanzapine | RxReference drug |
| Zyprexa Zydis20MG · tablet, orally disintegrating;oral | Olanzapine | RxReference drug |
| Jan 30, 2026 | Supplement 53Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 50Labeling · Standard review | Approved | |
| Apr 23, 2020 | Supplement 48Labeling · Standard review | Approved | |
| Apr 21, 2020 | Supplement 49Labeling | Approved | |
| Oct 22, 2019 | Supplement 47Labeling · Standard review | Approved | |
| Mar 27, 2018 | Supplement 46Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 45Labeling | Approved | |
| Feb 23, 2017 | Supplement 44Labeling · Standard review | Approved | |
| Oct 6, 2016 | Supplement 43Labeling | Approved | |
| Jul 23, 2015 | Supplement 42Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 40Labeling · Standard review | Approved | |
| Jul 26, 2013 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Jun 21, 2011 | Supplement 39REMS | Approved | |
| Jun 21, 2011 | Supplement 38REMS | Approved | |
| Dec 1, 2010 | Supplement 36Labeling | Approved | |
| May 27, 2010 | Supplement 34Labeling | Approved | |
| May 27, 2010 | Supplement 32Labeling | Approved | |
| Jan 27, 2010 | Supplement 31Labeling | Approved | |
| Aug 31, 2009 | Supplement 30Labeling | Approved | |
| Mar 19, 2009 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Aug 14, 2008 | Supplement 28Labeling · Standard review | Approved | |
| Jul 6, 2007 | Supplement 23Labeling · Standard review | Approved | |
| Jul 6, 2007 | Supplement 22Labeling · Standard review | Approved | |
| Nov 29, 2006 | Supplement 20Labeling · Standard review | Approved | |
| Aug 25, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Feb 23, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 16, 2006 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 13, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Oct 24, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 6, 2000 | 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
