Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021520
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 3MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/24/2003 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520_symbyax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21520ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21520_SymbyaxTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021520s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018936Orig1s112,021520Orig1s055ltr.pdf | |
| 09/20/2021 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021520Orig1s054ltr.pdf | |
| 04/21/2020 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021520s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020592Orig1s075,021086Orig1s049,021253Orig1s062,022173Orig1s036,021520Orig1s053ltr.pdf | |
| 03/04/2021 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021520Orig1s052ltr.pdf | |
| 10/23/2020 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021520s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021520Orig1s051ltr.pdf | |
| 03/27/2018 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021520s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021520Orig1s050ltr.pdf | |
| 02/23/2017 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021520Orig1s048,s049ltr.pdf | |
| 02/23/2017 | SUPPL-48 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021520Orig1s048,s049ltr.pdf |
| 01/04/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s108,021235Orig1s026,021520Orig1s047ltr.pdf | |
| 10/06/2016 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021520s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf | |
| 07/18/2014 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf | |
| 10/30/2014 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s103,021235Orig1s023,021520Orig1s042ltr.pdf | |
| 10/10/2014 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf | |
| 08/07/2013 | SUPPL-40 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s040ltr.pdf | |
| 07/26/2013 | SUPPL-39 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf | |
| 08/08/2012 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021520s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021520Orig1s038ltr.pdf | |
| 07/26/2013 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf | |
| 01/03/2013 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s035,s036ltr.pdf | |
| 01/03/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s035,s036ltr.pdf | |
| 12/19/2014 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf | |
| 10/04/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s033ltr.pdf | |
| 06/21/2011 | SUPPL-32 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf | |
| 06/21/2011 | SUPPL-31 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf | |
| 12/01/2010 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s027,s029ltr.pdf | |
| 04/22/2011 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,028ltr.pdf | |
| 12/01/2010 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s027,s029ltr.pdf | |
| 04/22/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,s028ltr.pdf | |
| 01/27/2010 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s023ltr.pdf | |
| 08/31/2009 | SUPPL-22 | Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s022lbl.pdf | |
| 08/14/2008 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s020ltr.pdf |
| 03/21/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s017ltr.pdf | |
| 03/18/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s016ltr.pdf | |
| 08/02/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf | |
| 08/02/2007 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf | |
| 03/19/2009 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data, REMS-Proposal |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021520Orig1s012.pdf | |
| 09/20/2006 | SUPPL-11 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s011lbl.pdf | |
| 04/09/2007 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021520s008, 010ltr.pdf | |
| 11/29/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021520s009ltr.pdf | |
| 04/09/2007 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021520s008, 010ltr.pdf | |
| 07/03/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/03/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/18/2005 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21520s005ltr.pdf |
| 07/03/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021520s055lbl.pdf | |
| 08/18/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021520s055lbl.pdf | |
| 09/20/2021 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s054lbl.pdf | |
| 09/20/2021 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s054lbl.pdf | |
| 03/04/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s052lbl.pdf | |
| 10/23/2020 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021520s051lbl.pdf | |
| 04/21/2020 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021520s053lbl.pdf | |
| 03/27/2018 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021520s050lbl.pdf | |
| 03/24/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s042lbl.pdf | |
| 02/23/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s049lbl.pdf | |
| 01/04/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s047lbl.pdf | |
| 10/06/2016 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021520s046lbl.pdf | |
| 10/06/2016 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021520s046lbl.pdf | |
| 12/19/2014 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s034lbl.pdf | |
| 10/10/2014 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s041lbl.pdf | |
| 07/18/2014 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s045lbl.pdf | |
| 08/07/2013 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s040lbl.pdf | |
| 07/26/2013 | SUPPL-39 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf | |
| 07/26/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf | |
| 01/03/2013 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf | |
| 01/03/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf | |
| 01/03/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf | |
| 08/08/2012 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021520s038lbl.pdf | |
| 10/04/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s33lbl.pdf | |
| 06/21/2011 | SUPPL-32 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf | |
| 06/21/2011 | SUPPL-31 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf | |
| 04/22/2011 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf | |
| 04/22/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf | |
| 12/01/2010 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf | |
| 12/01/2010 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf | |
| 01/27/2010 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s023lbl.pdf | |
| 08/31/2009 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s022lbl.pdf | |
| 03/19/2009 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s012lbl.pdf | |
| 03/19/2009 | SUPPL-12 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s012lbl.pdf | |
| 03/21/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s017lbl.pdf | |
| 03/18/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s016lbl.pdf | |
| 08/02/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf | |
| 08/02/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf | |
| 04/09/2007 | SUPPL-10 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf | |
| 04/09/2007 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf | |
| 11/29/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s009lbl.pdf | |
| 09/20/2006 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s011lbl.pdf | |
| 12/24/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520_symbyax_lbl.pdf |
SYMBYAX
CAPSULE;ORAL; EQ 25MG BASE;EQ 3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077742 | PAR PHARM |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202074 | TEVA PHARMS |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 3MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021520 | LILLY |
CAPSULE;ORAL; EQ 25MG BASE;EQ 6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077742 | PAR PHARM |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077528 | TEVA PHARMS |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021520 | LILLY |
CAPSULE;ORAL; EQ 50MG BASE;EQ 6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077742 | PAR PHARM |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077528 | TEVA PHARMS |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021520 | LILLY |
CAPSULE;ORAL; EQ 25MG BASE;EQ 12MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077742 | PAR PHARM |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077528 | TEVA PHARMS |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021520 | LILLY |
CAPSULE;ORAL; EQ 50MG BASE;EQ 12MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077742 | PAR PHARM |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077528 | TEVA PHARMS |
| SYMBYAX | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021520 | LILLY |