Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020919
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEODON | ZIPRASIDONE MESYLATE | EQ 20MG BASE/VIAL | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 06/21/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20919lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20919ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-919_Geodon.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/18/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020825s062,020919s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020825Orig1s062;020919Orig1s050ltr.pdf | |
| 10/29/2020 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825Orig1s061,020919Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020825Orig1s061,020919Orig1s049ltr.pdf | |
| 11/05/2018 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020825s059,020919s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020825Orig1s059,020919Orig1s047ltr.pdf | |
| 01/23/2020 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825s058,020919s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020825Orig1s058,020919Orig1s045ltr.pdf | |
| 02/23/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020825Orig1s056,021483Orig1s015,020919Orig1s044ltr.pdf | |
| 08/20/2015 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf | |
| 12/10/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf | |
| 06/09/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s049,020919Orig1s035ltr.pdf | |
| 08/13/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf | |
| 03/01/2013 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf | |
| 07/03/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf | |
| 12/01/2010 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf | |
| 07/19/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s035,020919s023ltr.pdf | |
| 12/19/2008 | SUPPL-22 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020919s022ltr.pdf |
| 08/14/2008 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s030, 020919s021ltr.pdf |
| 05/16/2008 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s027,020919s019ltr.pdf |
| 10/02/2007 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s026, 020919s016ltr.pdf | |
| 05/24/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014ltr.pdf | |
| 03/02/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s021, 020919s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020919_s012_GEODON.pdf | |
| 08/17/2005 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf | |
| 08/17/2005 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf | |
| 08/13/2004 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr.pdf |
| 12/23/2003 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20825slr008,20919slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/18/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020825s062,020919s050lbl.pdf | |
| 10/29/2020 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825Orig1s061,020919Orig1s049lbl.pdf | |
| 01/23/2020 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825s058,020919s045lbl.pdf | |
| 11/05/2018 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020825s059,020919s047lbl.pdf | |
| 02/23/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf | |
| 08/20/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf | |
| 12/10/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf | |
| 12/17/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf | |
| 08/13/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf | |
| 07/03/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf | |
| 03/01/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf | |
| 12/01/2010 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf | |
| 07/19/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf | |
| 10/02/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf | |
| 05/24/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf | |
| 03/02/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf | |
| 08/17/2005 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf | |
| 08/17/2005 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf | |
| 06/21/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20919lbl.pdf |
GEODON
POWDER;INTRAMUSCULAR; EQ 20MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEODON | ZIPRASIDONE MESYLATE | EQ 20MG BASE/VIAL | POWDER;INTRAMUSCULAR | Prescription | Yes | AP | 020919 | VIATRIS |
| ZIPRASIDONE MESYLATE | ZIPRASIDONE MESYLATE | EQ 20MG BASE/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AP | 211908 | GLAND PHARMA LTD |
| ZIPRASIDONE MESYLATE | ZIPRASIDONE MESYLATE | EQ 20MG BASE/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AP | 216091 | MSN |