Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022008
Company: GLAXOSMITHKLINE LLC
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XL | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 | Discontinued | None | Yes | No |
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | 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-Container/Carton Labels, Labeling-Package Insert |
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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf | |
| 10/31/2008 | SUPPL-1 | Labeling-Package Insert | 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 | 091395 | CELLTRION |
| 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 |
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 | 091395 | CELLTRION |
| 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 |
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 | 091395 | CELLTRION |
| 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 |
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