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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022008
Company: GLAXOSMITHKLINE LLC

Products on NDA 022008

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
REQUIP XL	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022008

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr_FINAL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022008_requip_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022008s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022008Orig1s012, s013ltr.pdf
07/12/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022008s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022008Orig1s012, s013ltr.pdf
03/23/2017	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022008Orig1s009ltr.pdf
08/28/2014	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf
08/28/2014	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf
08/28/2014	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf
08/28/2014	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf
04/10/2009	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022008s002ltr.pdf
10/31/2008	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s001ltr.pdf

Labels for NDA 022008

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022008s012s013lbl.pdf
07/12/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022008s012s013lbl.pdf
03/23/2017	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022008s009lbl.pdf
08/28/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf
08/28/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf
08/28/2014	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf
08/28/2014	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf
04/10/2009	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf
04/10/2009	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf
10/31/2008	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf
10/31/2008	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf
06/13/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008lbl.pdf

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