Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204026
Company: CELGENE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POMALYST POMALIDOMIDE 1MG CAPSULE;ORAL Prescription None Yes No
POMALYST POMALIDOMIDE 2MG CAPSULE;ORAL Prescription None Yes No
POMALYST POMALIDOMIDE 3MG CAPSULE;ORAL Prescription None Yes No
POMALYST POMALIDOMIDE 4MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/08/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204026Orig1s021ltr.pdf
12/29/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s019ltr.pdf
11/30/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s018ltr.pdf
03/20/2018 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204026Orig1s017ltr.pdf
06/27/2017 SUPPL-16 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s016ltr.pdf
06/30/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf
04/22/2016 SUPPL-13 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s013ltr.pdf
06/30/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf
12/01/2015 SUPPL-11 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s011ltr.pdf
10/27/2015 SUPPL-10 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s010ltr.pdf
09/14/2015 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s009ltr.pdf
04/23/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf
04/23/2015 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf
04/23/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf
09/12/2014 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s004ltr.pdf
03/13/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s003ltr.pdf
11/15/2013 SUPPL-2 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s002ltr.pdf
10/03/2013 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
10/30/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf
03/20/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf
12/29/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s019lbl.pdf
11/30/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s018lbl.pdf
06/30/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf
06/30/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf
04/23/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf
04/23/2015 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf
04/23/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf
03/13/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf
02/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf

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