Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022173
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYPREXA RELPREVV | OLANZAPINE PAMOATE | EQ 210MG BASE/VIAL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | No |
| ZYPREXA RELPREVV | OLANZAPINE PAMOATE | EQ 300MG BASE/VIAL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | No |
| ZYPREXA RELPREVV | OLANZAPINE PAMOATE | EQ 405MG BASE/VIAL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2026 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022173s043lbl022173s040lbl.pdf | |
| 05/07/2026 | SUPPL-43 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022173s043lbl022173s040lbl.pdf | |
| 05/07/2026 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022173s043lbl022173s040lbl.pdf | |
| 05/07/2026 | SUPPL-40 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022173s043lbl022173s040lbl.pdf | |
| 01/30/2026 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/22173s050lbl.pdf | |
| 01/22/2025 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022173s047lbl.pdf | |
| 04/23/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s034lbl.pdf | |
| 04/21/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s036lbl.pdf | |
| 10/22/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022173s030lbl.pdf | |
| 04/11/2019 | SUPPL-32 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022173s032lbl.pdf | |
| 03/27/2018 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022173s029lbl.pdf | |
| 11/30/2017 | SUPPL-27 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s027lbl.pdf | |
| 02/23/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf | |
| 02/23/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf | |
| 10/06/2016 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf | |
| 10/06/2016 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf | |
| 07/23/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022173s017lbl.pdf | |
| 12/19/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s015lbl.pdf | |
| 10/30/2014 | SUPPL-23 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s023lbl.pdf | |
| 03/27/2013 | SUPPL-18 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022173s018lbl.pdf | |
| 08/03/2012 | SUPPL-14 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf | |
| 08/03/2012 | SUPPL-10 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf | |
| 08/03/2012 | SUPPL-10 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf | |
| 08/03/2012 | SUPPL-8 | REMS | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf | |
| 12/01/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s009lbl.pdf | |
| 05/27/2010 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf | |
| 05/27/2010 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf | |
| 04/27/2010 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s002lbl.pdf | |
| 12/11/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022173lbl.pdf |