Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020658
Company: GLAXOSMITHKLINE LLC

• Other Important Information from FDA

Products on NDA 20658

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
REQUIP	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 020658

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2021	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020658s038lbl.pdf
04/03/2020	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020658Orig1s037lbl.pdf
05/05/2017	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020658s034lbl.pdf
09/09/2016	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020658s033lbl.pdf
08/28/2014	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf
08/28/2014	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf
08/28/2014	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf
08/28/2014	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf
08/28/2014	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf
12/31/2008	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf
12/31/2008	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf
12/31/2008	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf
05/04/2005	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020658s013lbl.pdf