Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021520
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
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021520s046lbl.pdf
10/06/2016 SUPPL-46 Labeling-Medication Guide 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 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
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 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
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 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
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 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
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 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
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

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