Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021253
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYPREXA | OLANZAPINE | 10MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/2026 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/21253s067lbl.pdf | |
| 01/22/2025 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020592s077,021086s050,021253s047s066lbl.pdf | |
| 04/23/2020 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s074,021086s048,021253s061lbl.pdf | |
| 04/21/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf | |
| 10/22/2019 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020592s072,021086s047,021253s060lbl.pdf | |
| 03/27/2018 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf | |
| 02/23/2017 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf | |
| 02/23/2017 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf | |
| 10/06/2016 | SUPPL-56 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf | |
| 10/06/2016 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf | |
| 07/23/2015 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf | |
| 12/19/2014 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf | |
| 12/01/2010 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf | |
| 05/27/2010 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf | |
| 05/27/2010 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf | |
| 01/27/2010 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf | |
| 08/31/2009 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf | |
| 07/06/2007 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf | |
| 11/29/2006 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf | |
| 08/25/2006 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf | |
| 02/23/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf | |
| 02/16/2006 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf | |
| 02/16/2006 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf | |
| 03/29/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21253_zyprexa_lbl.pdf |