Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021086
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYPREXA ZYDIS OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes Yes
ZYPREXA ZYDIS OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
ZYPREXA ZYDIS OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
ZYPREXA ZYDIS OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;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
04/06/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21086ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-086_ZyprexaZydis.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2018 SUPPL-46 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-45 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-44 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-43 Labeling-Package Insert, Labeling-Medication Guide 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
07/23/2015 SUPPL-42 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf
07/26/2013 SUPPL-41 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-40 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-39 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-38 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-36 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-34 Labeling Label (PDF)
Letter (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
05/27/2010 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (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
01/27/2010 SUPPL-31 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-30 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-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf
07/06/2007 SUPPL-23 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-22 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
03/19/2009 SUPPL-21 Efficacy-Labeling Change With Clinical Data, REMS-Proposal Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf
11/29/2006 SUPPL-20 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-16 Labeling Label (PDF)
Letter (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
09/13/2005 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf
02/16/2006 SUPPL-13 Labeling

Label is not available on this site.

08/25/2006 SUPPL-11 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-9 Labeling

Label is not available on this site.

10/24/2001 SUPPL-3 Manufacturing (CMC)-Control

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-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf
02/23/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf
02/23/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf
10/06/2016 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf
10/06/2016 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf
07/23/2015 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf
12/19/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf
07/26/2013 SUPPL-41 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf
06/21/2011 SUPPL-39 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf
06/21/2011 SUPPL-38 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf
12/01/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf
05/27/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf
05/27/2010 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf
01/27/2010 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf
08/31/2009 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf
03/19/2009 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf
03/19/2009 SUPPL-21 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf
07/06/2007 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf
07/06/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf
11/29/2006 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf
08/25/2006 SUPPL-11 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
04/06/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21086lbl.pdf

ZYPREXA ZYDIS

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN PHARMS INC
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN PHARMS INC
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN PHARMS INC
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN PHARMS INC
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

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