Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021110
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RAPAMUNE SIROLIMUS 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s057lbl.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-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 201578 DR REDDYS LABS LTD

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 201578 DR REDDYS LABS LTD

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 201676 ZYDUS PHARMS

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