Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022173
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-39 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022173Orig1s039ltr.pdf |
| 01/13/2021 | SUPPL-37 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022173Orig1s037ltr.pdf |
| 04/21/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020592Orig1s075,021086Orig1s049,021253Orig1s062,022173Orig1s036,021520Orig1s053ltr.pdf | |
| 04/22/2020 | SUPPL-35 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022173Orig1s035ltr.pdf |
| 04/23/2020 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020592Orig1s074, 021086Orig1s048, 021253Orig1s061, 022173Orig1s034ltr.pdf | |
| 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 | |
| 10/22/2019 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022173s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020592Orig1s072, 021086Orig1s047, 021253Orig1s060, 022173Orig1s030ltr.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-Medication Guide, Labeling-Package Insert |
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-Assessment, 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 | |
| 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 |
|---|---|---|---|---|---|
| 04/23/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s034lbl.pdf | |
| 04/21/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s036lbl.pdf | |
| 10/22/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022173s030lbl.pdf | |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf | |
| 10/06/2016 | SUPPL-25 | Labeling-Package Insert | 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-Assessment | 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-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 |