Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021829
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEUPRO ROTIGOTINE 2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes Yes
NEUPRO ROTIGOTINE 4MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
NEUPRO ROTIGOTINE 6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
NEUPRO ROTIGOTINE 1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
NEUPRO ROTIGOTINE 3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
NEUPRO ROTIGOTINE 8MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
05/09/2007 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021829s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021829s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2019 SUPPL-16 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021829s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021829Orig1s016ltr.pdf
11/29/2018 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021829s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021829Orig1s015ltr.pdf
01/30/2017 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/03/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/26/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021829s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021829Orig1s007ltr.pdf
04/02/2012 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf
04/02/2012 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/18/2019 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021829s016lbl.pdf
11/29/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021829s015lbl.pdf
11/29/2018 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021829s015lbl.pdf
02/26/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021829s007lbl.pdf
04/02/2012 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s002lbl.pdf
04/02/2012 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s001lbl.pdf
05/09/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829lbl.pdf

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