Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021253
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYPREXA OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/29/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21253_zyprexa_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21253ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21253_Zyprexa.TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2019 SUPPL-60 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-59 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-58 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-57 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-56 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
10/27/2016 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

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)
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
12/01/2010 SUPPL-45 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
09/30/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/27/2010 SUPPL-43 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-39 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-37 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-36 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-33 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-26 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
11/29/2006 SUPPL-21 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-12 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-6 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-4 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf
10/06/2016 SUPPL-56 Labeling-Medication Guide 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

ZYPREXA

INJECTABLE;INTRAMUSCULAR; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription No AP 201741 AM REGENT
OLANZAPINE OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription No AP 201588 SANDOZ INC
ZYPREXA OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription Yes AP 021253 LILLY

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