Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020592
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYPREXA | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZYPREXA | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| ZYPREXA | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZYPREXA | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZYPREXA | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZYPREXA | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/30/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020592_Original_Approval_Pkg .pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/21/2020 | SUPPL-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020592Orig1s075,021086Orig1s049,021253Orig1s062,022173Orig1s036,021520Orig1s053ltr.pdf | |
| 04/23/2020 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s074,021086s048,021253s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020592Orig1s074, 021086Orig1s048, 021253Orig1s061, 022173Orig1s034ltr.pdf | |
| 10/22/2019 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020592s072,021086s047,021253s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020592Orig1s072, 021086Orig1s047, 021253Orig1s060, 022173Orig1s030ltr.pdf | |
| 03/27/2018 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020592Orig1s071,021086Orig1s046,021253Orig1s059,022173Orig1s029ltr.pdf | |
| 02/23/2017 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf | |
| 02/23/2017 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf | |
| 10/06/2016 | SUPPL-67 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf | |
| 10/25/2013 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/2013 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/2015 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf | |
| 07/26/2013 | SUPPL-63 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf | |
| 12/19/2014 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf | |
| 06/21/2011 | SUPPL-61 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf | |
| 06/21/2011 | SUPPL-60 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf | |
| 12/01/2010 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf | |
| 05/27/2010 | SUPPL-55 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020592Orig1s055.pdf | |
| 05/27/2010 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020592Orig1s053.pdf | |
| 01/27/2010 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf | |
| 08/31/2009 | SUPPL-51 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf | |
| 08/14/2008 | SUPPL-49 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020592Orig1s049.pdf |
| 07/06/2007 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf | |
| 07/06/2007 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf | |
| 12/04/2009 | SUPPL-41 | Efficacy-New Patient Population, REMS-Proposal |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s040s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cfm | |
| 12/04/2009 | SUPPL-40 | Efficacy-New Patient Population, REMS-Proposal |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s040s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cfm | |
| 03/19/2009 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data, REMS-Proposal |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/Zyprexa_20592s39_toc.cfm | |
| 11/29/2006 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf | |
| 02/23/2006 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020592Orig1s035.pdf | |
| 09/13/2005 | SUPPL-34 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020592_s034_Zyprexa Tabs.pdf |
| 02/16/2006 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf | |
| 08/25/2006 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf | |
| 02/16/2006 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf | |
| 08/03/2005 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s026ltr.pdf |
| 06/29/2005 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s020ltr.pdf |
| 01/14/2004 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-019_zyprexa_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20592se1-019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020592_s019_Zyprexa.pdf | |
| 07/10/2003 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20592s18lbl_Zyprexa.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20592se1-018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020592_S018_ZYPREXA_AP.pdf | |
| 01/22/2002 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/13/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-11 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-592S011_review.pdf |
| 01/11/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/23/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/2000 | SUPPL-6 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020592_S006_ZUPREXA_ORAL_TABS_AP.pdf |
| 12/04/1997 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/23/2020 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s074,021086s048,021253s061lbl.pdf | |
| 04/21/2020 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf | |
| 10/22/2019 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020592s072,021086s047,021253s060lbl.pdf | |
| 03/27/2018 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf | |
| 02/23/2017 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf | |
| 02/23/2017 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf | |
| 10/06/2016 | SUPPL-67 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf | |
| 10/06/2016 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf | |
| 07/23/2015 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf | |
| 12/19/2014 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf | |
| 07/26/2013 | SUPPL-63 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf | |
| 06/21/2011 | SUPPL-61 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf | |
| 06/21/2011 | SUPPL-60 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf | |
| 12/01/2010 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf | |
| 05/27/2010 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf | |
| 05/27/2010 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf | |
| 01/27/2010 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf | |
| 12/04/2009 | SUPPL-41 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf | |
| 12/04/2009 | SUPPL-41 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf | |
| 12/04/2009 | SUPPL-40 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf | |
| 12/04/2009 | SUPPL-40 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf | |
| 08/31/2009 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf | |
| 03/19/2009 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf | |
| 03/19/2009 | SUPPL-39 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf | |
| 07/06/2007 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf | |
| 07/06/2007 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf | |
| 11/29/2006 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf | |
| 08/25/2006 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf | |
| 02/23/2006 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf | |
| 02/16/2006 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf | |
| 02/16/2006 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf | |
| 01/14/2004 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-019_zyprexa_lbl.pdf | |
| 07/10/2003 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20592s18lbl_Zyprexa.pdf |
ZYPREXA
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 206155 | INDOCO |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 091038 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 206155 | INDOCO |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 091038 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 206155 | INDOCO |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 091038 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 206155 | INDOCO |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 091038 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076133 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 206155 | INDOCO |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 091038 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 076133 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 206155 | INDOCO |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 091038 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |