Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022173
Company: ELI LILLY CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYPREXA RELPREVV OLANZAPINE PAMOATE EQ 210MG BASE/VIAL SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes No
ZYPREXA RELPREVV OLANZAPINE PAMOATE EQ 300MG BASE/VIAL SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes No
ZYPREXA RELPREVV OLANZAPINE PAMOATE EQ 405MG BASE/VIAL SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None 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
12/11/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022173lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022173s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173_zyprexa_relprevv_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2019 SUPPL-32 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022173s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022173Orig1s032ltr.pdf
03/27/2018 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022173s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020592Orig1s071,021086Orig1s046,021253Orig1s059,022173Orig1s029ltr.pdf
02/23/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf
11/30/2017 SUPPL-27 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022173Orig1s027ltr.pdf
02/23/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf
10/06/2016 SUPPL-25 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf
09/17/2015 SUPPL-24 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022173Orig1s024ltr.pdf
10/30/2014 SUPPL-23 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022173Orig1s023ltr.pdf
02/18/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/23/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/27/2013 SUPPL-18 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022173s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022173Orig1s018ltr.pdf
07/23/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022173s017lbl.pdf
12/19/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf
08/03/2012 SUPPL-14 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s014ltr.pdf
08/03/2012 SUPPL-10 REMS-Modified, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s014ltr.pdf
12/01/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s009ltr.pdf
08/03/2012 SUPPL-8 REMS Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173Orig1s008,s010,s014_r_ltr.pdf
05/27/2010 SUPPL-6 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf
07/08/2010 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s004ltr.pdf
05/27/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf
04/27/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/11/2019 SUPPL-32 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022173s032lbl.pdf
03/27/2018 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022173s029lbl.pdf
11/30/2017 SUPPL-27 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s027lbl.pdf
02/23/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf
02/23/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf
10/06/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf
10/06/2016 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf
07/23/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022173s017lbl.pdf
12/19/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s015lbl.pdf
10/30/2014 SUPPL-23 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s023lbl.pdf
03/27/2013 SUPPL-18 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022173s018lbl.pdf
08/03/2012 SUPPL-14 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf
08/03/2012 SUPPL-10 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf
08/03/2012 SUPPL-10 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf
08/03/2012 SUPPL-8 REMS Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf
12/01/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s009lbl.pdf
05/27/2010 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf
05/27/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf
04/27/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s002lbl.pdf
12/11/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022173lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English