Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022008
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
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
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-Container/Carton Labels, Labeling-Package Insert 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-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf
04/10/2009 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf
10/31/2008 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf
10/31/2008 SUPPL-1 Labeling-Container/Carton Labels 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

REQUIP XL

TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 12MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

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