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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020658
Company: GLAXOSMITHKLINE LLC
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REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020658_requip_toc.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020658s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020658Orig1s038ltr.pdf
04/03/2020 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020658Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020658Orig1s037ltr.pdf
05/05/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020658s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020658Orig1s034ltr.pdf
09/09/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020658s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020658Orig1s033ltr.pdf
08/28/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf
03/19/2012 SUPPL-31 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020658s031ltr.pdf
08/28/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf
08/28/2014 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf
08/28/2014 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf
08/28/2014 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf
12/31/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf
12/31/2008 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf
12/31/2008 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf
05/04/2005 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020658s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020658s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020658Orig1s013.pdf
06/19/2003 SUPPL-12 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20658slr012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020658_s012_RequipTOC.cfm
10/22/2002 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/05/2001 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/03/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 SUPPL-7 Labeling

Label is not available on this site.

11/02/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/16/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 SUPPL-3 Labeling

Label is not available on this site.

01/27/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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
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