Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021110
Company: PF PRISM CV
Company: PF PRISM CV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RAPAMUNE | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
| RAPAMUNE | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| RAPAMUNE | SIROLIMUS | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| RAPAMUNE | SIROLIMUS | 0.5MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/25/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21110ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2022 | SUPPL-88 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021083s069s070,021110s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021083Orig1s069,s070; 021110Orig1s087,s088ltr.pdf | |
| 08/22/2022 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021083s069s070,021110s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021083Orig1s069,s070; 021110Orig1s087,s088ltr.pdf | |
| 08/09/2021 | SUPPL-86 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021110s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021110Orig1s086ltr.pdf | |
| 01/02/2020 | SUPPL-85 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021083Orig1s067, 021110Orig1s085ltr.pdf | |
| 04/05/2019 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s065,021110s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021083Orig1s065, 021110Orig1s084ltr.pdf | |
| 07/15/2019 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s064,021110s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021083Orig1s064, 021110Orig1s083ltr.pdf | |
| 01/12/2018 | SUPPL-81 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021083Orig1s062, 021110Orig1s081ltr.pdf | |
| 05/23/2018 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021083Orig1s061,021110Orig1s080ltr.pdf | |
| 04/11/2017 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021083s059,021110s076lbl.pdf | |
| 11/05/2015 | SUPPL-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s058,021110Orig1075ltr.pdf | |
| 03/06/2015 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s056,021110Orig1s074ltr.pdf | |
| 05/28/2015 | SUPPL-73 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s055,021110Orig1s073ltr.pdf | |
| 03/30/2015 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2014 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2013 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2013 | SUPPL-68 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021110s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021110Orig1s068,021083Orig1s054ltr.pdf | |
| 03/07/2013 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021083Orig1s053,021110Orig1s067ltr.pdf | |
| 12/10/2012 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021083Orig1s051,021110Orig1s065ltr.pdf | |
| 06/06/2011 | SUPPL-60 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s050,021110s060ltr.pdf |
| 07/11/2011 | SUPPL-59 | Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s049,021110s059ltr.pdf |
| 11/08/2010 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s048,021110s058ltr.pdf | |
| 11/23/2010 | SUPPL-57 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf | |
| 07/02/2010 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s046,021110s056ltr.pdf | |
| 11/23/2010 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf | |
| 04/22/2010 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf | |
| 04/22/2010 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf | |
| 01/25/2010 | SUPPL-52 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s045,021110s052ltr.pdf | |
| 10/08/2009 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021110s051,021083s041ltr.pdf | |
| 09/24/2009 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s040,021110s050ltr.pdf | |
| 01/29/2009 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s038,021110s049ltr.pdf | |
| 03/05/2008 | SUPPL-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf |
| 03/05/2008 | SUPPL-47 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf |
| 10/17/2007 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s034,021110s045ltr.pdf | |
| 01/14/2008 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s033,021110s043_CKD.pdf | |
| 05/02/2007 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s031,021110s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039ltr.pdf | |
| 01/12/2007 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030, 021110s038ltr.pdf | |
| 01/30/2007 | SUPPL-37 | Efficacy-New Patient Population |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s029, 021110s037ltr.pdf |
| 10/19/2006 | SUPPL-36 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf | |
| 01/09/2007 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s026, 021110s035_ltr.pdf | |
| 06/02/2006 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf | |
| 03/10/2006 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2006 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf | |
| 10/07/2005 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf | |
| 10/07/2005 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf | |
| 06/30/2005 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf | |
| 06/30/2005 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf | |
| 03/11/2005 | SUPPL-24 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21083s019,21110s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr.pdf | |
| 07/20/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21083s017,21110s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr.pdf | |
| 02/23/2004 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21110scf018_rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21110scf018ltr.pdf | |
| 10/02/2003 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr015ltr.pdf | |
| 03/19/2003 | SUPPL-14 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf | |
| 03/19/2003 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr014ltr.pdf | |
| 01/31/2003 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021110s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr012,%2021110slr011ltr.pdf | |
| 01/23/2003 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf | |
| 01/23/2003 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf | |
| 06/05/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf | |
| 05/07/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf | |
| 04/11/2003 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083se1-006,21110se1-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021083_S006_RAPAMUNE.pdf | |
| 08/22/2002 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21110scf003ltr.pdf |
| 09/06/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/2003 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/22/2022 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021083s069s070,021110s087s088lbl.pdf | |
| 08/22/2022 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021083s069s070,021110s087s088lbl.pdf | |
| 08/09/2021 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021110s086lbl.pdf | |
| 01/02/2020 | SUPPL-85 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf | |
| 01/02/2020 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf | |
| 07/15/2019 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s064,021110s083lbl.pdf | |
| 04/05/2019 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s065,021110s084lbl.pdf | |
| 05/23/2018 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf | |
| 01/12/2018 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf | |
| 01/12/2018 | SUPPL-81 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf | |
| 04/11/2017 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021083s059,021110s076lbl.pdf | |
| 11/05/2015 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf | |
| 05/28/2015 | SUPPL-73 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf | |
| 03/06/2015 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf | |
| 05/30/2013 | SUPPL-68 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021110s068lbl.pdf | |
| 03/07/2013 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf | |
| 12/10/2012 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf | |
| 11/23/2010 | SUPPL-57 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s057lbl.pdf | |
| 11/23/2010 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s057lbl.pdf | |
| 11/23/2010 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s055lbl.pdf | |
| 11/08/2010 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s058lbl.pdf | |
| 07/02/2010 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf | |
| 04/22/2010 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf | |
| 04/22/2010 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf | |
| 01/25/2010 | SUPPL-52 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf |
| 10/08/2009 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf | |
| 09/24/2009 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf | |
| 01/29/2009 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf | |
| 01/14/2008 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf | |
| 10/17/2007 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf | |
| 05/02/2007 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s031,021110s039lbl.pdf | |
| 01/12/2007 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf | |
| 01/09/2007 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf | |
| 10/19/2006 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf | |
| 06/02/2006 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf | |
| 06/02/2006 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf | |
| 10/07/2005 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf | |
| 10/07/2005 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf | |
| 06/30/2005 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf | |
| 06/30/2005 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf | |
| 03/11/2005 | SUPPL-24 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21083s019,21110s024lbl.pdf | |
| 07/20/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21083s017,21110s020lbl.pdf | |
| 02/23/2004 | SUPPL-18 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21110scf018_rapamune_lbl.pdf | |
| 10/02/2003 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf | |
| 04/11/2003 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf | |
| 03/19/2003 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf | |
| 03/19/2003 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf | |
| 01/31/2003 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021110s011lbl.pdf | |
| 01/23/2003 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf | |
| 01/23/2003 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf | |
| 01/23/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf | |
| 01/23/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf | |
| 01/23/2003 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf | |
| 08/25/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune_prntlbl.pdf |
RAPAMUNE
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RAPAMUNE | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | Yes | AB | 021110 | PF PRISM CV |
| SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 214753 | ALKEM LABS LTD |
| SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 201578 | DR REDDYS |
| SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 208691 | GLENMARK PHARMS LTD |
| SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 201676 | ZYDUS PHARMS |
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RAPAMUNE | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | Yes | AB | 021110 | PF PRISM CV |
| SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 214753 | ALKEM LABS LTD |
| SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 201578 | DR REDDYS |
| SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 208691 | GLENMARK PHARMS LTD |
| SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 201676 | ZYDUS PHARMS |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RAPAMUNE | SIROLIMUS | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 021110 | PF PRISM CV |
| SIROLIMUS | SIROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 214753 | ALKEM LABS LTD |
| SIROLIMUS | SIROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 208691 | GLENMARK PHARMS LTD |
| SIROLIMUS | SIROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 201676 | ZYDUS PHARMS |