Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021880
Company: CELGENE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REVLIMID LENALIDOMIDE 5MG CAPSULE;ORAL Prescription None Yes No
REVLIMID LENALIDOMIDE 10MG CAPSULE;ORAL Prescription None Yes No
REVLIMID LENALIDOMIDE 15MG CAPSULE;ORAL Prescription None Yes No
REVLIMID LENALIDOMIDE 25MG CAPSULE;ORAL Prescription None Yes Yes
REVLIMID LENALIDOMIDE 2.5MG CAPSULE;ORAL Prescription None Yes No
REVLIMID LENALIDOMIDE 20MG CAPSULE;ORAL Prescription 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
12/27/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021880rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021880s000_RevlimidTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2017 SUPPL-51 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s051ltr.pdf
06/27/2017 SUPPL-50 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s050ltr.pdf
02/22/2017 SUPPL-49 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s049ltr.pdf
04/22/2016 SUPPL-47 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021880Orig1s047ltr.pdf
12/01/2015 SUPPL-46 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s046ltr.pdf
10/27/2015 SUPPL-45 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s045ltr.pdf
09/13/2015 SUPPL-44 REMS-Modified, REMS Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s044ltr.pdf
02/17/2015 SUPPL-41 Efficacy-New Indication, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s041ltr.pdf
09/12/2014 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf
09/12/2014 SUPPL-39 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf
11/04/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s038ltr.pdf
12/19/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/15/2013 SUPPL-35 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s035ltr.pdf
06/05/2013 SUPPL-34 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s034ltr.pdf
02/08/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf
05/09/2012 SUPPL-31 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s031ltr.pdf
02/08/2013 SUPPL-29 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf
03/12/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s028ltr.pdf
12/21/2011 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021880s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021880s023ltr.pdf
10/12/2010 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s018ltr.pdf
02/23/2009 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf
02/23/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf
08/03/2010 SUPPL-13 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s013ltr.pdf
02/23/2009 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf
06/29/2006 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021880s001.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021880s001LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2017 SUPPL-51 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s051lbl.pdf
02/22/2017 SUPPL-49 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s049lbl.pdf
02/17/2015 SUPPL-41 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf
02/17/2015 SUPPL-41 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf
09/12/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf
09/12/2014 SUPPL-39 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf
11/04/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf
06/05/2013 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s034lbl.pdf
02/08/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf
02/08/2013 SUPPL-29 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf
05/09/2012 SUPPL-31 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031lbl.pdf
03/12/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s028lbl.pdf
12/21/2011 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021880s023lbl.pdf
10/12/2010 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s018lbl.pdf
08/03/2010 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf
08/03/2010 SUPPL-13 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf
02/23/2009 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf
02/23/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf
02/23/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf
06/29/2006 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021880s001.pdf
12/27/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf

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