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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021829
Company: UCB INC

Products on NDA 021829

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021829

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
07/12/2021	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021829s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021829Orig1s021, s022ltr.pdf
07/12/2021	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021829s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021829Orig1s021, s022ltr.pdf
04/03/2020	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021829s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021829Orig1s019ltr.pdf
04/24/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021829s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021829Orig1s017ltr.pdf
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

Labels for NDA 021829

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-22	Labeling-Patient 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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021829s019lbl.pdf
04/03/2020	SUPPL-19	Labeling-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-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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