Documents
Application Sponsors
| NDA 022008 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | 1 | REQUIP XL | ROPINIROLE HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | REQUIP XL | ROPINIROLE HYDROCHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | 1 | REQUIP XL | ROPINIROLE HYDROCHLORIDE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE | 1 | REQUIP XL | ROPINIROLE HYDROCHLORIDE |
| 005 | TABLET, EXTENDED RELEASE;ORAL | EQ 12MG BASE | 1 | REQUIP XL | ROPINIROLE HYDROCHLORIDE |
| 006 | TABLET, EXTENDED RELEASE;ORAL | EQ 6MG BASE | 1 | REQUIP XL | ROPINIROLE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2008-06-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2009-04-10 | N/A |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2014-08-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2017-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-07-12 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 22008
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"REQUIP XL","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REQUIP XL","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"REQUIP XL","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"REQUIP XL","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"REQUIP XL","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REQUIP XL","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/23\/2017","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022008s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022008s003s004s007s008lbledt.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022008s003s004s007s008lbledt.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022008s003s004s007s008lbledt.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022008s003s004s007s008lbledt.pdf\"}]","notes":""},{"actionDate":"04\/10\/2009","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022008s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2009","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022008s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2008","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022008s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2008","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022008s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022008lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"REQUIP XL","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP XL","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP XL","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP XL","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP XL","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 12MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP XL","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 6MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-03-23
)
)