Treats schizophrenia. NDA 22173, held by Cheplapharm. Olanzapine Pamoate.
As of Nov 13, 2026, NDA 22173 (Zyprexa Relprevv), held by Cheplapharm, was first approved by FDA on Dec 11, 2009, with 31 approved supplements and 0 published complete response letters.
ZYPREXA RELPREVV is available only through a restricted distribution program. ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare setting, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV REMS. To enroll, call 1-877-772-9390. ZYPREXA RELPREVV is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia. Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults. 1.1 Schizophrenia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Zyprexa RelprevvEQ 210MG BASE/VIAL · suspension, extended release;intramuscular | Olanzapine Pamoate | RxReference drug |
| Zyprexa RelprevvEQ 300MG BASE/VIAL · suspension, extended release;intramuscular | Olanzapine Pamoate | RxReference drug |
| Zyprexa RelprevvEQ 405MG BASE/VIAL · suspension, extended release;intramuscular | Olanzapine Pamoate | RxReference drug |
| May 7, 2026 | Supplement 43Labeling · Standard review | Approved | |
| May 7, 2026 | Supplement 40REMS | Approved | |
| Jan 30, 2026 | Supplement 50Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 47Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 39REMS | Approved | |
| Jan 13, 2021 | Supplement 37Labeling · Standard review | Approved | |
| Apr 23, 2020 | Supplement 34Labeling · Standard review | Approved | |
| Apr 22, 2020 | Supplement 35REMS | Approved | |
| Apr 21, 2020 | Supplement 36Labeling | Approved | |
| Oct 22, 2019 | Supplement 30Labeling · Standard review | Approved | |
| Apr 11, 2019 | Supplement 32REMS | Approved | |
| Mar 27, 2018 | Supplement 29Labeling · Standard review | Approved | |
| Nov 30, 2017 | Supplement 27REMS | Approved | |
| Feb 23, 2017 | Supplement 28Labeling | Approved | |
| Feb 23, 2017 | Supplement 26Labeling · Standard review | Approved | |
| Oct 6, 2016 | Supplement 25Labeling | Approved | |
| Dec 23, 2015 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 17, 2015 | Supplement 24Labeling · Standard review | Approved | |
| Jul 23, 2015 | Supplement 17Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 15Labeling · Standard review | Approved | |
| Oct 30, 2014 | Supplement 23REMS | Approved | |
| Feb 18, 2014 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2013 | Supplement 18REMS | Approved | |
| Aug 3, 2012 | Supplement 14REMS | Approved | |
| Aug 3, 2012 | Supplement 10REMS | Approved | |
| Aug 3, 2012 | Supplement 8REMS | Approved | |
| Dec 1, 2010 | Supplement 9Labeling | Approved | |
| Jul 8, 2010 | Supplement 4REMS | Approved | |
| May 27, 2010 | Supplement 6Labeling | Approved | |
| May 27, 2010 | Supplement 3Labeling | Approved | |
| Apr 27, 2010 | Supplement 2Labeling | Approved | |
| Dec 11, 2009 | 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
