Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021445
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZETIA | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/25/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21445ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21445_Zetia.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/21/2024 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021445s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021445Orig1s043ltr.pdf | |
| 07/20/2023 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021445s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021445Orig1s042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021445Orig1s042.pdf | |
| 10/03/2019 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21445Orig1s040lbl1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021445Orig1s040ltr.pdf | |
| 09/30/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021445Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021445Orig1s037ltr.pdf | |
| 06/04/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/2013 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2012 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021445s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021445s033ltr.pdf | |
| 07/29/2011 | SUPPL-30 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021445s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021445s030ltr.pdf | |
| 07/21/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf | |
| 07/21/2009 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf | |
| 01/27/2009 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s025ltr.pdf | |
| 06/05/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf | |
| 06/05/2008 | SUPPL-20 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf | |
| 02/07/2008 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s019ltr.pdf | |
| 12/10/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021445s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021445s018ltr.pdf | |
| 11/02/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s016ltr.pdf | |
| 03/16/2006 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf | |
| 01/19/2006 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s014ltr.pdf | |
| 05/23/2006 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s013LTR.pdf | |
| 03/16/2006 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf | |
| 03/22/2005 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s011ltr.pdf | |
| 03/02/2005 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s007ltr.pdf | |
| 09/22/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s006ltr.pdf |
| 07/23/2004 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf | |
| 07/23/2004 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf | |
| 12/10/2007 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/2004 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2024 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021445s043lbl.pdf | |
| 07/20/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021445s042lbl.pdf | |
| 10/03/2019 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21445Orig1s040lbl1.pdf | |
| 09/30/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021445Orig1s037lbl.pdf | |
| 01/24/2012 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021445s033lbl.pdf | |
| 07/29/2011 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021445s030lbl.pdf | |
| 07/21/2009 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf | |
| 07/21/2009 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf | |
| 01/27/2009 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf | |
| 01/27/2009 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf | |
| 06/05/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf | |
| 06/05/2008 | SUPPL-20 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf | |
| 02/07/2008 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf | |
| 12/10/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021445s018lbl.pdf | |
| 11/02/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s016lbl.pdf | |
| 05/23/2006 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s013lbl.pdf | |
| 03/16/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf | |
| 03/16/2006 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf | |
| 01/19/2006 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s014lbl.pdf | |
| 03/22/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s011lbl.pdf | |
| 03/02/2005 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s007lbl.pdf | |
| 07/23/2004 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf | |
| 07/23/2004 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf | |
| 07/23/2004 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf | |
| 10/25/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf |
ZETIA
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 211550 | ACCORD HLTHCARE |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 209234 | ALKEM LABS LTD |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 208803 | AMNEAL PHARMS CO |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 209838 | AUROBINDO PHARMA |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 078560 | GLENMARK PHARMS LTD |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 210859 | HETERO LABS LTD III |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 207311 | OHM LABS INC |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 215693 | ORIENT PHARMA |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 203931 | SANDOZ |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 210673 | SCIEGEN PHARMS INC |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 200831 | WATSON LABS INC |
| EZETIMIBE | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | No | AB | 204331 | ZYDUS PHARMS |
| ZETIA | EZETIMIBE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021445 | ORGANON |