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Drugs@FDA: FDA-Approved Drugs

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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2021 SUPPL-22 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021829s021s022lbl.pdf
07/12/2021 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021829s021s022lbl.pdf
07/12/2021 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021829s021s022lbl.pdf
04/24/2020 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021829s017lbl.pdf
04/03/2020 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021829s019lbl.pdf
04/03/2020 SUPPL-19 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021829s019lbl.pdf
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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021829s015lbl.pdf
11/29/2018 SUPPL-15 Labeling-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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