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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 TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Discontinued None Yes No
REQUIP ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Discontinued None Yes No
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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