Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020658
Company: GLAXOSMITHKLINE LLC
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| ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |