Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020785
Company: CELGENE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THALOMID THALIDOMIDE 50MG CAPSULE;ORAL Prescription None Yes No
THALOMID THALIDOMIDE 100MG CAPSULE;ORAL Prescription None Yes No
THALOMID THALIDOMIDE 200MG CAPSULE;ORAL Prescription None Yes Yes
THALOMID THALIDOMIDE 150MG 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
07/16/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20785ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020785s000_ThalidomideTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/29/2017 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s065ltr.pdf
11/30/2017 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s064ltr.pdf
06/27/2017 SUPPL-63 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s063ltr.pdf
01/27/2017 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s061ltr.pdf
04/22/2016 SUPPL-60 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020785Orig1s060ltr.pdf
12/01/2015 SUPPL-59 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s059ltr.pdf
10/27/2015 SUPPL-58 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s058ltr.pdf
09/13/2015 SUPPL-57 REMS-Modified, REMS Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s057ltr.pdf
06/19/2014 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020785s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s055ltr.pdf
09/12/2014 SUPPL-54 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s054ltr.pdf
08/05/2015 SUPPL-51 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s051ltr.pdf
11/15/2013 SUPPL-50 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s050ltr.pdf
02/08/2013 SUPPL-48 REMS-Assessment, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s048ltr.pdf
02/03/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf
02/03/2012 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf
08/03/2010 SUPPL-39 Labeling, REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020785s039ltr.pdf
02/03/2012 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf
01/10/2007 SUPPL-32 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020785s032_ltr.pdf
05/25/2006 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000, 020785s031LTR.pdf
03/05/2004 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf
03/05/2004 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf
10/27/2003 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf
10/27/2003 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf
10/27/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf
01/17/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S021_THALOMID.pdf
01/17/2003 SUPPL-20 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S020_THALOMID.pdf
11/16/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/01/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/04/2001 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf
09/04/2001 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf
04/03/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/29/2017 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf
11/30/2017 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s064lbl.pdf
01/27/2017 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s061lbl.pdf
08/05/2015 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf
08/05/2015 SUPPL-51 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf
06/19/2014 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020785s055lbl.pdf
02/08/2013 SUPPL-48 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf
02/08/2013 SUPPL-48 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf
02/03/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf
02/03/2012 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf
02/03/2012 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf
05/25/2006 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf
10/27/2003 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf
10/27/2003 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf
10/27/2003 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf
01/17/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf
01/17/2003 SUPPL-20 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf
09/04/2001 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf
09/04/2001 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf
07/16/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf

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