Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019766
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOCOR | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZOCOR | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZOCOR | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZOCOR | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZOCOR | SIMVASTATIN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2023 | SUPPL-104 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019766Orig1s104ltr.pdf | |
| 03/14/2023 | SUPPL-103 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766Orig1s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019766Orig1s103ltr.pdf | |
| 05/31/2022 | SUPPL-102 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019766s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019766Orig1s102ltr.pdf | |
| 09/25/2020 | SUPPL-101 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019766s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019766Orig1s101ltr.pdf | |
| 10/04/2019 | SUPPL-100 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019766Orig1s100ltr.pdf | |
| 03/07/2022 | SUPPL-99 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019766s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019766Orig1s099ltr.pdf | |
| 02/28/2018 | SUPPL-98 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019766s098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019766Orig1s098ltr.pdf | |
| 03/01/2016 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/2015 | SUPPL-93 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019766Orig1s093ltr.pdf | |
| 03/01/2019 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019766Orig1s092ltr.pdf | |
| 02/27/2014 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019766Orig1s091ltr.pdf | |
| 10/25/2013 | SUPPL-90 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019766Orig1s090ltr.pdf | |
| 10/31/2012 | SUPPL-88 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf | |
| 10/31/2012 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf | |
| 11/15/2012 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-85 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766s085ltr.pdf | |
| 10/06/2011 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766Orig1s083.pdf | |
| 06/08/2011 | SUPPL-82 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf | |
| 11/04/2010 | SUPPL-81 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s081ltr.pdf | |
| 04/08/2010 | SUPPL-80 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s080ltr.pdf | |
| 06/10/2011 | SUPPL-79 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
| 03/02/2010 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s078ltr.pdf | |
| 06/08/2011 | SUPPL-77 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766s077.pdf | |
| 06/11/2008 | SUPPL-76 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019766s076ltr.pdf | |
| 11/26/2007 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s075ltr.pdf | |
| 06/01/2007 | SUPPL-74 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s074ltr.pdf | |
| 05/17/2005 | SUPPL-70 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s070ltr.pdf | |
| 08/31/2005 | SUPPL-69 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s069ltr.pdf | |
| 02/24/2004 | SUPPL-68 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf | |
| 02/24/2004 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf | |
| 09/17/2003 | SUPPL-66 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf | |
| 09/17/2003 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf | |
| 04/16/2003 | SUPPL-58 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766se1-058ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019766_S058_ZOCOR_TABS_AP.pdf | |
| 05/06/2002 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/2002 | SUPPL-56 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766se5-056ltr.pdf | |
| 02/22/2002 | SUPPL-55 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S055_ZOCOR.pdf |
| 03/21/2002 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S054_ZOCOR.pdf |
| 11/14/2001 | SUPPL-53 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S053_ZOCOR.pdf | |
| 03/21/2002 | SUPPL-52 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s52ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-766s052_Zocor.cfm | |
| 05/06/2002 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s51ltr.pdf | |
| 09/13/2001 | SUPPL-50 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S050_ZOCOR.pdf |
| 06/04/2001 | SUPPL-49 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S049_ZOCOR.pdf |
| 04/10/2001 | SUPPL-48 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S048_ZOCOR.pdf |
| 04/10/2001 | SUPPL-47 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S047_ZOCOR.pdf |
| 11/14/2001 | SUPPL-45 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S045_ZOCOR.pdf |
| 12/11/2000 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S044_ZOCOR_TABLET.pdf |
| 04/14/2000 | SUPPL-43 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S043_ZOCOR_TABLETS.pdf |
| 11/07/2000 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-41 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_s041_ZOCOR_TABLETS.pdf |
| 04/27/2000 | SUPPL-40 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19766S40LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor.cfm | |
| 08/22/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-36 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf |
| 09/15/1999 | SUPPL-35 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s035_ZOCOR TABLETS.pdf |
| 11/22/1999 | SUPPL-34 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf |
| 03/22/1999 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_S033_ZOCOR_TABLET.pdf |
| 08/05/1999 | SUPPL-32 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19766s32ltr.pdf |
| 04/23/1999 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s031_ZOCOR_TABLETS.pdf |
| 09/24/1998 | SUPPL-30 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766_S030_ZOCOR_TABLETS.pdf |
| 06/29/1998 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766a_s029.pdf |
| 07/10/1998 | SUPPL-28 | Efficacy-New Dosing Regimen |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm |
| 03/31/1998 | SUPPL-27 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s27ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766s027_Zocor.cfm |
| 07/10/1998 | SUPPL-26 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm |
| 12/02/1997 | SUPPL-25 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S025_ZOCOR_TABLETS.pdf |
| 09/09/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S023_ZOCOR_TABLETS.pdf |
| 07/18/1997 | SUPPL-22 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S022_ZOCOR_TABLETS.pdf |
| 10/31/1997 | SUPPL-21 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/12/1997 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/17/1997 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1997 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766a_s018.pdf |
| 05/23/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/22/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_S016_ZOCOR_TABLETS.pdf |
| 08/01/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/09/1995 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s014_ZOCOR_TABLETS.pdf |
| 11/06/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s012_ZOCOR_TABLETS.pdf |
| 06/30/1995 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/21/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/19/1995 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s008_ZOCOR_TABLETS.pdf |
| 07/28/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/22/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/24/1993 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/09/2023 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766s104lbl.pdf | |
| 03/14/2023 | SUPPL-103 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766Orig1s103lbl.pdf | |
| 03/14/2023 | SUPPL-103 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766Orig1s103lbl.pdf | |
| 05/31/2022 | SUPPL-102 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019766s102lbl.pdf | |
| 03/07/2022 | SUPPL-99 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019766s099lbl.pdf | |
| 09/25/2020 | SUPPL-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019766s101lbl.pdf | |
| 10/04/2019 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s100lbl.pdf | |
| 03/01/2019 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s092lbl.pdf | |
| 02/28/2018 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019766s098lbl.pdf | |
| 02/02/2015 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf | |
| 02/27/2014 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf | |
| 10/25/2013 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf | |
| 10/31/2012 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf | |
| 10/31/2012 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf | |
| 02/28/2012 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf | |
| 10/06/2011 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf | |
| 06/08/2011 | SUPPL-82 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf | |
| 06/08/2011 | SUPPL-77 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf | |
| 11/04/2010 | SUPPL-81 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf | |
| 04/08/2010 | SUPPL-80 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf | |
| 03/02/2010 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf | |
| 06/11/2008 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf | |
| 11/26/2007 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf | |
| 06/01/2007 | SUPPL-74 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf | |
| 06/01/2007 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf | |
| 08/31/2005 | SUPPL-69 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf | |
| 05/17/2005 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf | |
| 02/24/2004 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf | |
| 02/24/2004 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf | |
| 09/17/2003 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf | |
| 09/17/2003 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf | |
| 04/16/2003 | SUPPL-58 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf | |
| 10/18/2002 | SUPPL-56 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf | |
| 05/06/2002 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf | |
| 03/21/2002 | SUPPL-52 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf | |
| 11/14/2001 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf | |
| 04/27/2000 | SUPPL-40 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf |
ZOCOR
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |